Endoscopy, Pancreas, & Biliary Tract

An elevated body mass index is not just associated with symptomatic gallstone disease, it appears to cause the disease, according to a report published in Hepatology (doi:10.1002/hep.26563).

Many epidemiologic and observational studies have noted a clear association between a high BMI and an increased risk for gallstones, but have not been able to pin down a causal effect. It was impossible to rule out confounding by some other factor, such as a high-fat diet, that simultaneously caused both the elevation in BMI and the elevation in risk for gallstones. Similarly, it was impossible to rule out reverse causation, such as the colicky pain of gallstone disease caused the physical inactivity that then led to a high BMI.

©istockphoto.com

A new epidemiologic statistical approach known as Mendelian randomization is thought to avert both confounding and reverse causation by pinpointing the genetic variants that are linked to a high BMI (which are a constant throughout the lifespan) but that are not related to confounding factors, then determining whether they are also linked to gallstone disease. "If raised BMI truly is a causal factor in the development of gallstone disease, genetic variants that increase BMI would be expected to also increase risk of gallstone disease," said Dr. Stefan Stender of the department of clinical biochemistry, Rigshospitalet, University of Copenhagen, and his associates.

They studied 77,679 Danish adults from the general population who participated in two large prospective studies: the Copenhagen General Population Study (67,314 subjects) and the Copenhagen City Heart Study (10,365 subjects). All the participants had donated blood samples that could be used for DNA extraction and genotyping.

A total of 4,106 of these subjects developed symptomatic gallstone disease during follow-up of up to 34 years.

The researchers used genotyping to identify study subjects who carried any of the three polymorphisms that have the largest known effect sizes for association with BMI in European populations: FTO (rs9939609), MC4R (rs17782313), or TMEM18 (rs6548238). Each of these can be carried on two possible alleles, so any given subject could carry one to six affected alleles. The number of BMI-increasing alleles, from one to six, was determined for each study subject.

In an initial analysis of the data, the mean baseline BMI was 55% higher (11 kg/m²) in subjects carrying the most alleles compared with those carrying the fewest.

Increasing BMI was associated with a stepwise increase in the risk of developing symptomatic gallstone disease.

In the overall cohort, the risk of symptomatic gallstone disease was increased 7% for every 1-kg/m² increase in BMI. In the Mendelian randomization cohort, the risk of gallstone disease increased 17% with every 1-kg/m² increase in BMI. The concordance between these two estimates indicates that BMI itself is a causal risk factor for symptomatic gallstone disease, Dr. Stender and his associates said.

This study did not include data on gallstone composition and was not designed to examine the pathophysiologic mechanisms by which a high BMI causes gallstone formation. However, numerous other studies have proposed several possible mechanisms, they noted.

Obesity may raise cholesterol synthesis and hepatobiliary cholesterol efflux, "a key event in the development of cholesterol gallstones." High abdominal fat mass may induce gallbladder hypomotility and bile stasis, "another risk factor for gallstone formation."

In addition, substances secreted by or metabolized by adipocytes could influence gallstone formation. For example, estrogen is produced by adipocytes and may promote gallstone formation by raising the rate of hepatobiliary cholesterol efflux. And leptin, which is also secreted by adipocytes, may have lithogenic effects.

Adinopectin, another hormone secreted by adipocytes, has been linked to gallstones in both animal and human studies. And obesity-associated hyperinsulinemia may induce gallstone formation by causing the secretion of more lithogenic bile.

This study was limited in that it included only white people of Danish descent. "Because ethnic differences in gallstone prevalence are well known, the results reported here may not necessarily translate to other ethnicities," Dr. Stender and his colleagues said.

This study was supported by the Danish Medical Research Council, the Rigshospitalet at Copenhagen University, and the Odd Fellow Order. No financial conflicts of interest were reported.

An elevated body mass index is not just associated with symptomatic gallstone disease, it appears to cause the disease, according to a report published in Hepatology (doi:10.1002/hep.26563).

Many epidemiologic and observational studies have noted a clear association between a high BMI and an increased risk for gallstones, but have not been able to pin down a causal effect. It was impossible to rule out confounding by some other factor, such as a high-fat diet, that simultaneously caused both the elevation in BMI and the elevation in risk for gallstones. Similarly, it was impossible to rule out reverse causation, such as the colicky pain of gallstone disease caused the physical inactivity that then led to a high BMI.

©istockphoto.com

A new epidemiologic statistical approach known as Mendelian randomization is thought to avert both confounding and reverse causation by pinpointing the genetic variants that are linked to a high BMI (which are a constant throughout the lifespan) but that are not related to confounding factors, then determining whether they are also linked to gallstone disease. "If raised BMI truly is a causal factor in the development of gallstone disease, genetic variants that increase BMI would be expected to also increase risk of gallstone disease," said Dr. Stefan Stender of the department of clinical biochemistry, Rigshospitalet, University of Copenhagen, and his associates.

They studied 77,679 Danish adults from the general population who participated in two large prospective studies: the Copenhagen General Population Study (67,314 subjects) and the Copenhagen City Heart Study (10,365 subjects). All the participants had donated blood samples that could be used for DNA extraction and genotyping.

A total of 4,106 of these subjects developed symptomatic gallstone disease during follow-up of up to 34 years.

The researchers used genotyping to identify study subjects who carried any of the three polymorphisms that have the largest known effect sizes for association with BMI in European populations: FTO (rs9939609), MC4R (rs17782313), or TMEM18 (rs6548238). Each of these can be carried on two possible alleles, so any given subject could carry one to six affected alleles. The number of BMI-increasing alleles, from one to six, was determined for each study subject.

In an initial analysis of the data, the mean baseline BMI was 55% higher (11 kg/m²) in subjects carrying the most alleles compared with those carrying the fewest.

Increasing BMI was associated with a stepwise increase in the risk of developing symptomatic gallstone disease.

In the overall cohort, the risk of symptomatic gallstone disease was increased 7% for every 1-kg/m² increase in BMI. In the Mendelian randomization cohort, the risk of gallstone disease increased 17% with every 1-kg/m² increase in BMI. The concordance between these two estimates indicates that BMI itself is a causal risk factor for symptomatic gallstone disease, Dr. Stender and his associates said.

This study did not include data on gallstone composition and was not designed to examine the pathophysiologic mechanisms by which a high BMI causes gallstone formation. However, numerous other studies have proposed several possible mechanisms, they noted.

Obesity may raise cholesterol synthesis and hepatobiliary cholesterol efflux, "a key event in the development of cholesterol gallstones." High abdominal fat mass may induce gallbladder hypomotility and bile stasis, "another risk factor for gallstone formation."

In addition, substances secreted by or metabolized by adipocytes could influence gallstone formation. For example, estrogen is produced by adipocytes and may promote gallstone formation by raising the rate of hepatobiliary cholesterol efflux. And leptin, which is also secreted by adipocytes, may have lithogenic effects.

Adinopectin, another hormone secreted by adipocytes, has been linked to gallstones in both animal and human studies. And obesity-associated hyperinsulinemia may induce gallstone formation by causing the secretion of more lithogenic bile.

This study was limited in that it included only white people of Danish descent. "Because ethnic differences in gallstone prevalence are well known, the results reported here may not necessarily translate to other ethnicities," Dr. Stender and his colleagues said.

This study was supported by the Danish Medical Research Council, the Rigshospitalet at Copenhagen University, and the Odd Fellow Order. No financial conflicts of interest were reported.

An elevated body mass index is not just associated with symptomatic gallstone disease, it appears to cause the disease, according to a report published in Hepatology (doi:10.1002/hep.26563).

Many epidemiologic and observational studies have noted a clear association between a high BMI and an increased risk for gallstones, but have not been able to pin down a causal effect. It was impossible to rule out confounding by some other factor, such as a high-fat diet, that simultaneously caused both the elevation in BMI and the elevation in risk for gallstones. Similarly, it was impossible to rule out reverse causation, such as the colicky pain of gallstone disease caused the physical inactivity that then led to a high BMI.

©istockphoto.com

A new epidemiologic statistical approach known as Mendelian randomization is thought to avert both confounding and reverse causation by pinpointing the genetic variants that are linked to a high BMI (which are a constant throughout the lifespan) but that are not related to confounding factors, then determining whether they are also linked to gallstone disease. "If raised BMI truly is a causal factor in the development of gallstone disease, genetic variants that increase BMI would be expected to also increase risk of gallstone disease," said Dr. Stefan Stender of the department of clinical biochemistry, Rigshospitalet, University of Copenhagen, and his associates.

They studied 77,679 Danish adults from the general population who participated in two large prospective studies: the Copenhagen General Population Study (67,314 subjects) and the Copenhagen City Heart Study (10,365 subjects). All the participants had donated blood samples that could be used for DNA extraction and genotyping.

A total of 4,106 of these subjects developed symptomatic gallstone disease during follow-up of up to 34 years.

The researchers used genotyping to identify study subjects who carried any of the three polymorphisms that have the largest known effect sizes for association with BMI in European populations: FTO (rs9939609), MC4R (rs17782313), or TMEM18 (rs6548238). Each of these can be carried on two possible alleles, so any given subject could carry one to six affected alleles. The number of BMI-increasing alleles, from one to six, was determined for each study subject.

In an initial analysis of the data, the mean baseline BMI was 55% higher (11 kg/m²) in subjects carrying the most alleles compared with those carrying the fewest.

Increasing BMI was associated with a stepwise increase in the risk of developing symptomatic gallstone disease.

In the overall cohort, the risk of symptomatic gallstone disease was increased 7% for every 1-kg/m² increase in BMI. In the Mendelian randomization cohort, the risk of gallstone disease increased 17% with every 1-kg/m² increase in BMI. The concordance between these two estimates indicates that BMI itself is a causal risk factor for symptomatic gallstone disease, Dr. Stender and his associates said.

This study did not include data on gallstone composition and was not designed to examine the pathophysiologic mechanisms by which a high BMI causes gallstone formation. However, numerous other studies have proposed several possible mechanisms, they noted.

Obesity may raise cholesterol synthesis and hepatobiliary cholesterol efflux, "a key event in the development of cholesterol gallstones." High abdominal fat mass may induce gallbladder hypomotility and bile stasis, "another risk factor for gallstone formation."

In addition, substances secreted by or metabolized by adipocytes could influence gallstone formation. For example, estrogen is produced by adipocytes and may promote gallstone formation by raising the rate of hepatobiliary cholesterol efflux. And leptin, which is also secreted by adipocytes, may have lithogenic effects.

Adinopectin, another hormone secreted by adipocytes, has been linked to gallstones in both animal and human studies. And obesity-associated hyperinsulinemia may induce gallstone formation by causing the secretion of more lithogenic bile.

This study was limited in that it included only white people of Danish descent. "Because ethnic differences in gallstone prevalence are well known, the results reported here may not necessarily translate to other ethnicities," Dr. Stender and his colleagues said.

This study was supported by the Danish Medical Research Council, the Rigshospitalet at Copenhagen University, and the Odd Fellow Order. No financial conflicts of interest were reported.

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

Should bariatric surgery be performed in certified centers only? Medicare officials think the answer might be "no."

In a proposed decision memo issued in June, the Centers for Medicare and Medicaid Services said the evidence was sufficient to end the certification requirement and that continuing the current requirements would not improve health outcomes for Medicare beneficiaries.

While some physician experts support the proposal as improving access to bariatric surgery, others express concerns that quality and data collection efforts will suffer.

The proposal does not change which procedures are covered by Medicare. The agency will continue to cover open and laparoscopic Roux-en-Y gastric bypass; laparoscopic adjustable gastric banding; and open and laparoscopic biliopancreatic diversion with duodenal switch for Medicare beneficiaries with a body-mass index of 35 kg/m² or greater who have at least one comorbidity related to obesity and have been unsuccessful with medical treatment for obesity.

If the proposal is accepted, it would reverse the requirements the CMS put in place in February 2006. Since then, Medicare has covered only bariatric procedures performed at facilities that were certified by the American College of Surgeons as a Level 1 Bariatric Surgery Center or by the American Society for Metabolic and Bariatric Surgery as a Bariatric Surgery Center of Excellence.

CMS officials reviewed eight studies to determine if facility certification meaningfully improved health outcomes for Medicare beneficiaries. The studies had "mixed" results, the agency said, but overall, the evidence showed "no consistent statistical or clinically meaningful difference" and there was nothing in the literature to suggest a worsening of outcomes.

The factors that led to the original certification requirements – the rapid growth in bariatric procedures and concerns about higher mortality rates – have changed.

"Since that 2006 determination, bariatric surgery has experienced a trend toward less invasive procedures and lower mortality and complication rates," according to the proposed decision memo.

The policy switch was requested by a trio of health services researchers at the University of Michigan led by Dr. John D. Birkmeyer, professor of surgery and director of the university’s Center for Healthcare Outcomes and Policy. They asserted that certified hospitals were no safer than other facilities and that mortality and serious complication rates for bariatric surgery had declined across the country.

They called on the CMS to scrap the certification requirements but to encourage bariatric surgeons to participate in registry programs through their professional societies or through payer-supported collaborative improvement programs such as the one supported by Blue Cross Blue Shield of Michigan.

The Michigan researchers suggested that the agency incentivize physicians to participate in these quality improvement activities by tying them to programs such as the Physician Quality Reporting System.

Dr. Birkmeyer pointed to a study published earlier this year showing that the current certification policy has not led to better outcomes for patients (JAMA 2013;309:792-9). In the study, which Dr. Birkmeyer coauthored, the researchers found no statistically significant improvements in complications or reoperation rates after implementation of the CMS certification requirements after accounting for patient factors, changes in procedure type, and pre-existing time trends toward improved outcomes.

"There is absolutely no controversy about the fact that [the policy] didn’t steer people to safer hospitals," Dr. Birkmeyer said.

Access could improve under the proposed decision memo, Dr. Birkmeyer said. The current certification framework makes it harder for some Medicare patients to undergo bariatric surgery without traveling hours from home. The policy may also be disproportionately affecting minorities and low-income beneficiaries, Dr. Birkmeyer said.

The American College of Surgeons and the American Society for Metabolic and Bariatric Surgery continue to support certification; however, they are working to revise their processes to create a single, unified program that will include a lower volume threshold for certification, dropping from a minimum of 125 cases a year to 50 cases a year, according to Dr. Jaime Ponce, president of the American Society for Metabolic and Bariatric Surgery and a bariatric surgeon in Chattanooga, Tenn.

The volume change should help to address some of the concerns about access by opening up certification to more programs, he said.

But Dr. Ponce said his group plans to fight the "dangerous" CMS proposal to drop certification requirements completely.

"We do believe that this could be very harmful for Medicare patients because if a patient that is very sick shows up in a community hospital that doesn’t have the right structure to take care of obese patients ... accidents are going to start happening again," he said.

The majority of the literature supports facility certification for bariatric surgery, Dr. Ponce said. As for those studies showing no difference in outcomes, the results weren’t reliable because the studies were conducted at a time when most of the facilities included were pursuing certification, he noted. Even those facilities that fell short of meeting certification requirements would have been developing a culture of safety and would likely have met many of the standards.

Dr. Ponce singled out a 2011 study in Annals of Surgery, which evaluated mortality among Medicare patients before and after the certification requirements took effect (Ann. Surg. 2011;254: 860-5). The study, which used Medicare data from 2004-2008, showed that mortality, readmission, and reoperation rates all declined after the coverage decision was implemented. The 90-day mortality rate dropped from 1.5% to 0.7%, while 90-day readmission rates decreased from 19.9% to 15.4%. The researchers also noted a decrease in payments for the procedures.

But gains in safety and cost-effectiveness could be lost if the CMS removes the certification requirements, Dr. Ponce said. Without clear requirements in place, hospitals will be unlikely to make the investments they are making today in equipment, personnel, and training, he said.

Another issue is what will happen to data collection if certification requirements are eliminated. Dr. Ponce said he’s concerned that data collection efforts would dry up without those mandates from the CMS.

"We will not have that data in order to improve the quality that we need to," he said.

A final decision on the coverage memo is expected in the fall.

mschneider@frontlinemedcom.com

The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

The accuracy of cyst fluid carcinoembryonic antigen in differentiating between benign and malignant pancreatic cysts is poor, and the antigen should not be used as a sole marker for guiding surgical decision making, results from a meta-analysis of available literature on the topic suggests.

"The clinical value of cyst fluid CEA should be limited only to distinguishing mucinous from nonmucinous cystic lesions," Dr. Saowanee Ngamruengphong and her colleagues from the division of gastroenterology and hepatology at Mayo Clinic Florida, Jacksonville, wrote in an article in Digestive and Liver Disease (2013 June 18 [doi: 10.1016/j.dld.2013.05.002]). "Large, multicentric, well-designed trials are needed to further characterize the role of cyst fluid tumor marker and molecular analysis in the evaluation of pancreatic cysts."

Results from two previously published articles in the medical literature showed that a cyst fluid EA level of 192-200 ng/mL had 80% accuracy in differentiating between mucinous and nonmucinous cysts (Gastroenterology 2004;126:1330-6 and Pancreatology 2012;12:183-97).

In an effort to determine the diagnostic accuracy of cyst fluid CEA in discriminating benign from malignant pancreatic cystic neoplasms, the authors of the current study conducted a literature search of Medline and Embase databases for studies published before October 2012. They used the following keywords: "pancreas OR pancreatic cystic lesion," "tumor marker OR carcinoembryonic antigen OR CEA," and "diagnosis." A total of eight published articles involving 504 patients were included in the final analysis. Random-effects models were used to calculate pooled estimates of diagnostic precision.

Dr. Ngamruengphong and her colleagues reported that the CEA cutoff level for determining a malignant cyst ranged from 109.9 to 6,000 mg/mL, and that the pooled sensitivity of cyst fluid CEA in the prediction of malignant pancreatic cysts was 63% while the pooled specificity was 63%. In addition, the positive likelihood ratio was 1.89, the negative likelihood ratio was 0.62, and the diagnostic odds ratio was 3.84.

A subgroup analysis of 227 patients with mucinous cysts revealed similar results: a pooled sensitivity of 65%, a pooled specificity of 66%, and a diagnostic odds ratio of 4.74.

"Our findings support the current guidelines, which do not recommend the use of fluid cyst CEA to diagnose malignant pancreatic cysts," the researchers wrote.

They acknowledged certain limitations of the study, including the fact that there was significant heterogeneity among the studies and that the small sample sizes in the included studies "could potentially be subject to selection bias."

The researchers stated that they had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

ORLANDO – Although obesity is more prevalent among blacks, fewer get bariatric surgery, and for those who do, the outcomes are less efficacious than for whites and Hispanics, according to analysis of a national database, examining the influence of ethnicity on bariatric surgery.

"All qualified obese patients, particularly the rapidly growing black population, need improved access to bariatric surgery to reduce mortality," said Dr. Ranjan Sudan, vice chair of education in the department of surgery at Duke University, Durham, N.C. He presented his unpublished abstract at the annual Digestive Disease Week.

Studies have shown that bariatric surgery is an effective treatment for obesity and decreases mortality, but the reason behind the disparity and surgery outcomes is rather nuanced and not so clear (N. Engl. J. Med. 2007;357:753-61).

A 2012 study at the Louisiana State University System, Baton Rouge, found that white females appeared to lose more weight than did black females regardless of the type of bariatric surgery, although both races experienced surgical complications. Also, "black patients may be less likely to undergo bariatric surgery without insurance coverage," the authors wrote (Adv. Ther. 2012;29:970-8).

Meanwhile, a 2012 meta-analysis looking at ethnic differences in weight loss and diabetes remission after bariatric surgery found that for the percentage of excess weight loss, bariatric surgery was more effective in whites than in blacks, regardless of procedure type. "Further studies are needed to investigate the exact mechanisms behind these disparities and to determine whether ethnic differences exist in the remission of comorbidities after bariatric surgery," the authors wrote (Diabetes Care 2012;35:1951-8).

"It could be because of underlying difference in physiology among races," an area that is still poorly-understood, Dr. Vic Velanovich, professor of medicine at the University of South Florida, Tampa, said in an interview. Also, "Is this a problem of geographic variation?" he said, commenting on Dr. Sudan’s findings. "Are blacks getting their health care in such a way that they don’t have access to bariatric surgery? And the third issue is cultural. It could be very well that [the] cultural view of body image is different. So there are a lot of unanswered questions," said Dr. Velanovich, who was not involved in the study.

Dr. Sudan and his colleagues examined the primary Roux-en-Y gastric bypass surgery (RYGB) data from the American Society for Bariatric and Metabolic Surgery database, submitted by more than 1,000 surgeons and 700 hospitals between June 2007 and September 2011.

All patients gave research consent and were eligible for 1-year follow-up.

Of the 135,000 patients, 79% were white, 12% black, and 9% Hispanic. Compared with whites at baseline, black patients were younger (43 years vs. 46 years), heavier (body mass index of 50 kg/m² vs. 48 kg/m²), and were more often hypertensive (58% vs. 53%).

Among black patients who were undergoing RYGB, 15% were male, compared with 23% white and 22% Hispanic males. More black patients had a history of hypertension (57%), compared with whites (52%) and Hispanics (41%). Hispanic patients had the least comorbid disease burden, said Dr. Sudan.

Meanwhile, more white patients had diabetes (32%), compared with Hispanics (31%) and blacks (30%), at baseline.

Follow up rates were 60% in white patients, 50% in Hispanics, and 49% in blacks.

Overall, the benefits of RYGB were significant in the three groups at 1-year follow-up, but the procedure was less efficient for black patients, according to the analysis.

For instance, although fewer black patients had diabetes at baseline, at 1-year follow-up a higher percentage of them had diabetes with less decline in diabetes rates (from 30% to 13%, decline of 59%), compared with whites (from 32% to 11%; –65%), and Hispanics (from 31% to 12%; –61%.)

Black patients also had less decline in the mean body mass index (–30%), compared with whites (–34%), and Hispanics (–32%). Their hypertension also declined less (–35%) than in whites (–49%), and Hispanics (–50%).

The mortality rates within 30 days were similar for all three group (0.23%-0.26%), but black patients had a higher rate of total adverse events (22%), compared with whites and Hispanics (17% each).

The study has some limitations, said Dr. Sudan. Some of the data is self-reported, and researchers did not stratify disease severity by ethnicity.

Recent studies shows that grade 2 or higher obesity (BMI of 35 or more) is most prevalent among blacks (26%), compared with whites (15%) and Hispanics (15%). The overall rate for all ethnicities is 15.5%. (JAMA 2012;307:491-7). Black women also have the highest rate of grade 2 or higher obesity (31%), followed by black men (21%), Hispanic women (18%), white women (17%), white men (12%), and Hispanic men (11.4%).

Dr. Sudan also pointed out that the black population has higher rates of hypertension and diabetes, compared with Hispanics and whites, while more white patients (56%) control their hypertension, compared with blacks (48%) and Hispanics (41%) (NCHS Data Brief 2012;107:1-8).

"Hypertension control is very important because hypertension is a risk factor for cardiovascular mortality," said Dr. Sudan. "If the medical control is not good, then we certainly want to consider bariatric surgery."

Dr. Sudan said the he’s planning on examining the database for geographic distribution and socioeconomic factors.

Dr. Sudan and Dr. Velanovich said they had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Although obesity is more prevalent among blacks, fewer get bariatric surgery, and for those who do, the outcomes are less efficacious than for whites and Hispanics, according to analysis of a national database, examining the influence of ethnicity on bariatric surgery.

"All qualified obese patients, particularly the rapidly growing black population, need improved access to bariatric surgery to reduce mortality," said Dr. Ranjan Sudan, vice chair of education in the department of surgery at Duke University, Durham, N.C. He presented his unpublished abstract at the annual Digestive Disease Week.

Studies have shown that bariatric surgery is an effective treatment for obesity and decreases mortality, but the reason behind the disparity and surgery outcomes is rather nuanced and not so clear (N. Engl. J. Med. 2007;357:753-61).

A 2012 study at the Louisiana State University System, Baton Rouge, found that white females appeared to lose more weight than did black females regardless of the type of bariatric surgery, although both races experienced surgical complications. Also, "black patients may be less likely to undergo bariatric surgery without insurance coverage," the authors wrote (Adv. Ther. 2012;29:970-8).

Meanwhile, a 2012 meta-analysis looking at ethnic differences in weight loss and diabetes remission after bariatric surgery found that for the percentage of excess weight loss, bariatric surgery was more effective in whites than in blacks, regardless of procedure type. "Further studies are needed to investigate the exact mechanisms behind these disparities and to determine whether ethnic differences exist in the remission of comorbidities after bariatric surgery," the authors wrote (Diabetes Care 2012;35:1951-8).

"It could be because of underlying difference in physiology among races," an area that is still poorly-understood, Dr. Vic Velanovich, professor of medicine at the University of South Florida, Tampa, said in an interview. Also, "Is this a problem of geographic variation?" he said, commenting on Dr. Sudan’s findings. "Are blacks getting their health care in such a way that they don’t have access to bariatric surgery? And the third issue is cultural. It could be very well that [the] cultural view of body image is different. So there are a lot of unanswered questions," said Dr. Velanovich, who was not involved in the study.

Dr. Sudan and his colleagues examined the primary Roux-en-Y gastric bypass surgery (RYGB) data from the American Society for Bariatric and Metabolic Surgery database, submitted by more than 1,000 surgeons and 700 hospitals between June 2007 and September 2011.

All patients gave research consent and were eligible for 1-year follow-up.

Of the 135,000 patients, 79% were white, 12% black, and 9% Hispanic. Compared with whites at baseline, black patients were younger (43 years vs. 46 years), heavier (body mass index of 50 kg/m² vs. 48 kg/m²), and were more often hypertensive (58% vs. 53%).

Among black patients who were undergoing RYGB, 15% were male, compared with 23% white and 22% Hispanic males. More black patients had a history of hypertension (57%), compared with whites (52%) and Hispanics (41%). Hispanic patients had the least comorbid disease burden, said Dr. Sudan.

Meanwhile, more white patients had diabetes (32%), compared with Hispanics (31%) and blacks (30%), at baseline.

Follow up rates were 60% in white patients, 50% in Hispanics, and 49% in blacks.

Overall, the benefits of RYGB were significant in the three groups at 1-year follow-up, but the procedure was less efficient for black patients, according to the analysis.

For instance, although fewer black patients had diabetes at baseline, at 1-year follow-up a higher percentage of them had diabetes with less decline in diabetes rates (from 30% to 13%, decline of 59%), compared with whites (from 32% to 11%; –65%), and Hispanics (from 31% to 12%; –61%.)

Black patients also had less decline in the mean body mass index (–30%), compared with whites (–34%), and Hispanics (–32%). Their hypertension also declined less (–35%) than in whites (–49%), and Hispanics (–50%).

The mortality rates within 30 days were similar for all three group (0.23%-0.26%), but black patients had a higher rate of total adverse events (22%), compared with whites and Hispanics (17% each).

The study has some limitations, said Dr. Sudan. Some of the data is self-reported, and researchers did not stratify disease severity by ethnicity.

Recent studies shows that grade 2 or higher obesity (BMI of 35 or more) is most prevalent among blacks (26%), compared with whites (15%) and Hispanics (15%). The overall rate for all ethnicities is 15.5%. (JAMA 2012;307:491-7). Black women also have the highest rate of grade 2 or higher obesity (31%), followed by black men (21%), Hispanic women (18%), white women (17%), white men (12%), and Hispanic men (11.4%).

Dr. Sudan also pointed out that the black population has higher rates of hypertension and diabetes, compared with Hispanics and whites, while more white patients (56%) control their hypertension, compared with blacks (48%) and Hispanics (41%) (NCHS Data Brief 2012;107:1-8).

"Hypertension control is very important because hypertension is a risk factor for cardiovascular mortality," said Dr. Sudan. "If the medical control is not good, then we certainly want to consider bariatric surgery."

Dr. Sudan said the he’s planning on examining the database for geographic distribution and socioeconomic factors.

Dr. Sudan and Dr. Velanovich said they had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Although obesity is more prevalent among blacks, fewer get bariatric surgery, and for those who do, the outcomes are less efficacious than for whites and Hispanics, according to analysis of a national database, examining the influence of ethnicity on bariatric surgery.

"All qualified obese patients, particularly the rapidly growing black population, need improved access to bariatric surgery to reduce mortality," said Dr. Ranjan Sudan, vice chair of education in the department of surgery at Duke University, Durham, N.C. He presented his unpublished abstract at the annual Digestive Disease Week.

Studies have shown that bariatric surgery is an effective treatment for obesity and decreases mortality, but the reason behind the disparity and surgery outcomes is rather nuanced and not so clear (N. Engl. J. Med. 2007;357:753-61).

A 2012 study at the Louisiana State University System, Baton Rouge, found that white females appeared to lose more weight than did black females regardless of the type of bariatric surgery, although both races experienced surgical complications. Also, "black patients may be less likely to undergo bariatric surgery without insurance coverage," the authors wrote (Adv. Ther. 2012;29:970-8).

Meanwhile, a 2012 meta-analysis looking at ethnic differences in weight loss and diabetes remission after bariatric surgery found that for the percentage of excess weight loss, bariatric surgery was more effective in whites than in blacks, regardless of procedure type. "Further studies are needed to investigate the exact mechanisms behind these disparities and to determine whether ethnic differences exist in the remission of comorbidities after bariatric surgery," the authors wrote (Diabetes Care 2012;35:1951-8).

"It could be because of underlying difference in physiology among races," an area that is still poorly-understood, Dr. Vic Velanovich, professor of medicine at the University of South Florida, Tampa, said in an interview. Also, "Is this a problem of geographic variation?" he said, commenting on Dr. Sudan’s findings. "Are blacks getting their health care in such a way that they don’t have access to bariatric surgery? And the third issue is cultural. It could be very well that [the] cultural view of body image is different. So there are a lot of unanswered questions," said Dr. Velanovich, who was not involved in the study.

Dr. Sudan and his colleagues examined the primary Roux-en-Y gastric bypass surgery (RYGB) data from the American Society for Bariatric and Metabolic Surgery database, submitted by more than 1,000 surgeons and 700 hospitals between June 2007 and September 2011.

All patients gave research consent and were eligible for 1-year follow-up.

Of the 135,000 patients, 79% were white, 12% black, and 9% Hispanic. Compared with whites at baseline, black patients were younger (43 years vs. 46 years), heavier (body mass index of 50 kg/m² vs. 48 kg/m²), and were more often hypertensive (58% vs. 53%).

Among black patients who were undergoing RYGB, 15% were male, compared with 23% white and 22% Hispanic males. More black patients had a history of hypertension (57%), compared with whites (52%) and Hispanics (41%). Hispanic patients had the least comorbid disease burden, said Dr. Sudan.

Meanwhile, more white patients had diabetes (32%), compared with Hispanics (31%) and blacks (30%), at baseline.

Follow up rates were 60% in white patients, 50% in Hispanics, and 49% in blacks.

Overall, the benefits of RYGB were significant in the three groups at 1-year follow-up, but the procedure was less efficient for black patients, according to the analysis.

For instance, although fewer black patients had diabetes at baseline, at 1-year follow-up a higher percentage of them had diabetes with less decline in diabetes rates (from 30% to 13%, decline of 59%), compared with whites (from 32% to 11%; –65%), and Hispanics (from 31% to 12%; –61%.)

Black patients also had less decline in the mean body mass index (–30%), compared with whites (–34%), and Hispanics (–32%). Their hypertension also declined less (–35%) than in whites (–49%), and Hispanics (–50%).

The mortality rates within 30 days were similar for all three group (0.23%-0.26%), but black patients had a higher rate of total adverse events (22%), compared with whites and Hispanics (17% each).

The study has some limitations, said Dr. Sudan. Some of the data is self-reported, and researchers did not stratify disease severity by ethnicity.

Recent studies shows that grade 2 or higher obesity (BMI of 35 or more) is most prevalent among blacks (26%), compared with whites (15%) and Hispanics (15%). The overall rate for all ethnicities is 15.5%. (JAMA 2012;307:491-7). Black women also have the highest rate of grade 2 or higher obesity (31%), followed by black men (21%), Hispanic women (18%), white women (17%), white men (12%), and Hispanic men (11.4%).

Dr. Sudan also pointed out that the black population has higher rates of hypertension and diabetes, compared with Hispanics and whites, while more white patients (56%) control their hypertension, compared with blacks (48%) and Hispanics (41%) (NCHS Data Brief 2012;107:1-8).

"Hypertension control is very important because hypertension is a risk factor for cardiovascular mortality," said Dr. Sudan. "If the medical control is not good, then we certainly want to consider bariatric surgery."

Dr. Sudan said the he’s planning on examining the database for geographic distribution and socioeconomic factors.

Dr. Sudan and Dr. Velanovich said they had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

ORLANDO – Guidelines that attempt to predict whether stones have migrated into the common bile duct appear to get it right, said an investigator at the annual Digestive Disease Week.

A prospective study looking at American Society for Gastrointestinal Endoscopy (ASGE) criteria for evaluating patients with choledocholithiais found that the guidelines correctly predicted the presence of a common bile duct (CBD) stone in 75% of patients deemed to be at high risk, and accurately called the shots in 55% of patients at intermediate risk, reported Dr. Andrew Korson of Beth Israel Deaconess Medical Center in Boston.

The ASGE guidelines are intended to help clinicians decide whether and when an invasive procedure may be warranted, based on certain clinical features, Dr. Korson noted.

"In the past decade there has been heightened awareness of the problem of proper patient selection for endoscopic retrograde cholangiography [ERC] in the setting of suspected choledocholithiasis, and to date there has been no single noninvasive test that has been shown to reliably identify these patients," he said.

The ASGE guidelines stratify patients into high-risk (greater than 50% incidence of choledocholithiasis), intermediate-risk (10%-50% incidence), and low-risk (less than 10% incidence) categories based on the presence of specific predictive features.

Very strong predictors of choledocholithiasis are evidence of a CBD stone on transabdominal ultrasound, clinical ascending cholangitis, and a bilirubin level higher than 4 mg/dL. Strong predictors are a dilated CBD on ultrasound (greater than 6 mm with gallbladder in situ) and a bilirubin level from 1.8 to 4 mg/dL. Moderate predictors are an abnormal liver biochemical test other than bilirubin, age older than 55, and clinical gallstone pancreatitis.

High-risk patients under this classification scheme are those with any very strong predictor or both strong predictors. Patients at low risk are those with no predictors present, and those at intermediate risk are everyone in between.

Only some get stones

Dr. Korson and his colleagues looked at the proportion of patients within ASGE risk categories who actually had choledocholithiasis on ERC.

They enrolled 402 consecutive patients referred to the hospital for ERC for suspected choledocholithiasis.

They considered clinical, radiographic, and biochemical data at initial presentation, and used transabdominal ultrasound to measure the CBD diameter and the presence of echodensities suggestive of stones or, if ultrasound was not performed, CT or magnetic resonance cholangiopancreatography (MRCP) to gather evidence for choledocholithiasis.

The authors used the data to prospectively apply ASGE criteria and risk-stratify the patients.

Endoscopy was performed with either sphincterectomy or balloon sweep at the discretion of the attending gastroenterologist, with the endoscopist blinded to the risk category.

Of the 402 patients enrolled, 69 were excluded for anatomical reasons or because of a lack of complete data, leaving 333 for the final analysis.

Of the 243 patients classified as high risk, 183 (75.3%) were found to have a CBD stone, and 60 (24.7%) had no stone. Of the 88 at intermediate risk, 47 (53.4%) were found on ERC to have a stone, and 41 (46.6%) were not. Neither of the two low-risk patients had a stone.

The investigators determined the positive predictive value (PPV) of the ASGE criteria to be 55% for intermediate-risk patients, and 75% for high-risk patients (P for each less than .001).

In both univariate and multivariate analyses, only radiographic evidence of a CBD stone and elevated liver enzymes (aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase) were significant predictors of risk. Ascending cholangitis, a total bilirubin level above 4 mg/dL, dilated common bile duct, age, and gallstone pancreatitis were not significant independent predictors.

The odds ratio (OR) for choledocholithiasis based on CBD stone on radiographic evidence was 3.56 (P less than .001), and for elevated liver biochemical tests, was 2.26 (P = .03).

In a post hoc univariate analysis, each 10-IU/L increase in ALT, AST, and alkaline phosphatase was associated with a respective odds ratio of 1.01 (P = .04), 1.01 (P =.03), and 1.02 (P = .04) for choledocholithiasis.

Dr. Korson noted that based on the heavy weighting of their sample toward high- and intermediate-risk patients, "further evaluation of factors that separate intermediate- from low-risk patients is warranted."

He acknowledged study limitations, including possible referral bias, because all of the cases were evaluated at a tertiary care center, a high-acuity study population was used, and CT or MRCP was used to detect CBD dilation or a stone when ultrasound was unavailable.

The funding source for the study was not disclosed. Dr. Korson reported having no relevant financial disclosures.

ORLANDO – Guidelines that attempt to predict whether stones have migrated into the common bile duct appear to get it right, said an investigator at the annual Digestive Disease Week.

A prospective study looking at American Society for Gastrointestinal Endoscopy (ASGE) criteria for evaluating patients with choledocholithiais found that the guidelines correctly predicted the presence of a common bile duct (CBD) stone in 75% of patients deemed to be at high risk, and accurately called the shots in 55% of patients at intermediate risk, reported Dr. Andrew Korson of Beth Israel Deaconess Medical Center in Boston.

The ASGE guidelines are intended to help clinicians decide whether and when an invasive procedure may be warranted, based on certain clinical features, Dr. Korson noted.

"In the past decade there has been heightened awareness of the problem of proper patient selection for endoscopic retrograde cholangiography [ERC] in the setting of suspected choledocholithiasis, and to date there has been no single noninvasive test that has been shown to reliably identify these patients," he said.

The ASGE guidelines stratify patients into high-risk (greater than 50% incidence of choledocholithiasis), intermediate-risk (10%-50% incidence), and low-risk (less than 10% incidence) categories based on the presence of specific predictive features.

Very strong predictors of choledocholithiasis are evidence of a CBD stone on transabdominal ultrasound, clinical ascending cholangitis, and a bilirubin level higher than 4 mg/dL. Strong predictors are a dilated CBD on ultrasound (greater than 6 mm with gallbladder in situ) and a bilirubin level from 1.8 to 4 mg/dL. Moderate predictors are an abnormal liver biochemical test other than bilirubin, age older than 55, and clinical gallstone pancreatitis.

High-risk patients under this classification scheme are those with any very strong predictor or both strong predictors. Patients at low risk are those with no predictors present, and those at intermediate risk are everyone in between.

Only some get stones

Dr. Korson and his colleagues looked at the proportion of patients within ASGE risk categories who actually had choledocholithiasis on ERC.

They enrolled 402 consecutive patients referred to the hospital for ERC for suspected choledocholithiasis.

They considered clinical, radiographic, and biochemical data at initial presentation, and used transabdominal ultrasound to measure the CBD diameter and the presence of echodensities suggestive of stones or, if ultrasound was not performed, CT or magnetic resonance cholangiopancreatography (MRCP) to gather evidence for choledocholithiasis.

The authors used the data to prospectively apply ASGE criteria and risk-stratify the patients.

Endoscopy was performed with either sphincterectomy or balloon sweep at the discretion of the attending gastroenterologist, with the endoscopist blinded to the risk category.

Of the 402 patients enrolled, 69 were excluded for anatomical reasons or because of a lack of complete data, leaving 333 for the final analysis.

Of the 243 patients classified as high risk, 183 (75.3%) were found to have a CBD stone, and 60 (24.7%) had no stone. Of the 88 at intermediate risk, 47 (53.4%) were found on ERC to have a stone, and 41 (46.6%) were not. Neither of the two low-risk patients had a stone.

The investigators determined the positive predictive value (PPV) of the ASGE criteria to be 55% for intermediate-risk patients, and 75% for high-risk patients (P for each less than .001).

In both univariate and multivariate analyses, only radiographic evidence of a CBD stone and elevated liver enzymes (aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase) were significant predictors of risk. Ascending cholangitis, a total bilirubin level above 4 mg/dL, dilated common bile duct, age, and gallstone pancreatitis were not significant independent predictors.

The odds ratio (OR) for choledocholithiasis based on CBD stone on radiographic evidence was 3.56 (P less than .001), and for elevated liver biochemical tests, was 2.26 (P = .03).

In a post hoc univariate analysis, each 10-IU/L increase in ALT, AST, and alkaline phosphatase was associated with a respective odds ratio of 1.01 (P = .04), 1.01 (P =.03), and 1.02 (P = .04) for choledocholithiasis.

Dr. Korson noted that based on the heavy weighting of their sample toward high- and intermediate-risk patients, "further evaluation of factors that separate intermediate- from low-risk patients is warranted."

He acknowledged study limitations, including possible referral bias, because all of the cases were evaluated at a tertiary care center, a high-acuity study population was used, and CT or MRCP was used to detect CBD dilation or a stone when ultrasound was unavailable.

The funding source for the study was not disclosed. Dr. Korson reported having no relevant financial disclosures.

ORLANDO – Guidelines that attempt to predict whether stones have migrated into the common bile duct appear to get it right, said an investigator at the annual Digestive Disease Week.

A prospective study looking at American Society for Gastrointestinal Endoscopy (ASGE) criteria for evaluating patients with choledocholithiais found that the guidelines correctly predicted the presence of a common bile duct (CBD) stone in 75% of patients deemed to be at high risk, and accurately called the shots in 55% of patients at intermediate risk, reported Dr. Andrew Korson of Beth Israel Deaconess Medical Center in Boston.

The ASGE guidelines are intended to help clinicians decide whether and when an invasive procedure may be warranted, based on certain clinical features, Dr. Korson noted.

"In the past decade there has been heightened awareness of the problem of proper patient selection for endoscopic retrograde cholangiography [ERC] in the setting of suspected choledocholithiasis, and to date there has been no single noninvasive test that has been shown to reliably identify these patients," he said.

The ASGE guidelines stratify patients into high-risk (greater than 50% incidence of choledocholithiasis), intermediate-risk (10%-50% incidence), and low-risk (less than 10% incidence) categories based on the presence of specific predictive features.

Very strong predictors of choledocholithiasis are evidence of a CBD stone on transabdominal ultrasound, clinical ascending cholangitis, and a bilirubin level higher than 4 mg/dL. Strong predictors are a dilated CBD on ultrasound (greater than 6 mm with gallbladder in situ) and a bilirubin level from 1.8 to 4 mg/dL. Moderate predictors are an abnormal liver biochemical test other than bilirubin, age older than 55, and clinical gallstone pancreatitis.

High-risk patients under this classification scheme are those with any very strong predictor or both strong predictors. Patients at low risk are those with no predictors present, and those at intermediate risk are everyone in between.

Only some get stones

Dr. Korson and his colleagues looked at the proportion of patients within ASGE risk categories who actually had choledocholithiasis on ERC.

They enrolled 402 consecutive patients referred to the hospital for ERC for suspected choledocholithiasis.

They considered clinical, radiographic, and biochemical data at initial presentation, and used transabdominal ultrasound to measure the CBD diameter and the presence of echodensities suggestive of stones or, if ultrasound was not performed, CT or magnetic resonance cholangiopancreatography (MRCP) to gather evidence for choledocholithiasis.

The authors used the data to prospectively apply ASGE criteria and risk-stratify the patients.

Endoscopy was performed with either sphincterectomy or balloon sweep at the discretion of the attending gastroenterologist, with the endoscopist blinded to the risk category.

Of the 402 patients enrolled, 69 were excluded for anatomical reasons or because of a lack of complete data, leaving 333 for the final analysis.

Of the 243 patients classified as high risk, 183 (75.3%) were found to have a CBD stone, and 60 (24.7%) had no stone. Of the 88 at intermediate risk, 47 (53.4%) were found on ERC to have a stone, and 41 (46.6%) were not. Neither of the two low-risk patients had a stone.

The investigators determined the positive predictive value (PPV) of the ASGE criteria to be 55% for intermediate-risk patients, and 75% for high-risk patients (P for each less than .001).

In both univariate and multivariate analyses, only radiographic evidence of a CBD stone and elevated liver enzymes (aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase) were significant predictors of risk. Ascending cholangitis, a total bilirubin level above 4 mg/dL, dilated common bile duct, age, and gallstone pancreatitis were not significant independent predictors.

The odds ratio (OR) for choledocholithiasis based on CBD stone on radiographic evidence was 3.56 (P less than .001), and for elevated liver biochemical tests, was 2.26 (P = .03).

In a post hoc univariate analysis, each 10-IU/L increase in ALT, AST, and alkaline phosphatase was associated with a respective odds ratio of 1.01 (P = .04), 1.01 (P =.03), and 1.02 (P = .04) for choledocholithiasis.

Dr. Korson noted that based on the heavy weighting of their sample toward high- and intermediate-risk patients, "further evaluation of factors that separate intermediate- from low-risk patients is warranted."

He acknowledged study limitations, including possible referral bias, because all of the cases were evaluated at a tertiary care center, a high-acuity study population was used, and CT or MRCP was used to detect CBD dilation or a stone when ultrasound was unavailable.

The funding source for the study was not disclosed. Dr. Korson reported having no relevant financial disclosures.

ORLANDO – Home monitoring of select patients with mild, nonalcoholic acute interstitial pancreatitis is as safe as in-hospital monitoring, at a cost saving of nearly $15,000, according to a study presented at the annual Digestive Disease Week.

In a randomized controlled trial of 84 patients there were no cases of organ failure or pancreatic necrosis and no deaths within 30 days in patients assigned to either home or hospital monitoring. One patient in the home group and two in the hospital group required readmission within 30 days of discharge, reported Dr. Ali T. Ince of the Bezmialem Vakif University Medical Faculty Hospital in Istanbul, Turkey.

The total tab for home monitoring, including emergency department evaluation, intravenous therapy, and nursing visits, was $7,135, compared with $21,960 for in-hospital care, a savings of $14,825.

"Patients with mild nonalcoholic acute pancreatitis can be safely treated at home with regular visits by a nurse. Widespread adoption of this practice could result in large costs savings," Dr. Ince said.

In 2009, acute pancreatitis cases cost the U.S. health care system about $2.6 billion, for a median per patient charge of $6,096.

"The cost of severe acute pancreatitis is more than the cost of mild acute pancreatitis. However, since only 10%-15% of patients have severe acute pancreatitis, the majority of patients admitted have mild disease," he noted.

To see whether home care of such patients could be safely provided, the investigators enrolled patients admitted to the emergency department for evaluation of acute pancreatitis. Those with an Imrie scoring system value of 5 or lower, a Harmless Acute Pancreatitis Score (HAPS) of 2 or less, and a hematocrit of less than 44% were randomly assigned to either home or hospital monitoring, 42 patients in each group. All patients took nothing by mouth initially and had an oral diet gradually reintroduced.

Hospitalized patients were followed for a mean of 5 days. Home-treated patients received nurse visits on the second, third, and fifth day following discharge from the emergency department. At each home visit, nurses took vital signs, assessed symptoms, and evaluated patients’ general condition and transmitted the data to the attending physician. All patients were asked about their complaints and had physical and laboratory exams on day 7, day 14, and day 30.

Patients with organ failure, signs or symptoms of sepsis, alcoholic acute pancreatitis, prior evidence of a dilated pancreatic duct or pancreatic calcifications, coagulopathies, or comorbidities requiring hospitalization were excluded, Dr. Ince said.

All patients in each group were treated with lactated Ringer’s solution 100-150 mL/hour IV for 3 days, parenteral pantoprazole 40 mg/day, intramuscular diclofenac as needed for pain, and parenteral metoclopramide as needed for nausea, he noted.

In addition, those patients with acute biliary pancreatitis and concurrent cholangitis underwent endoscopic retrograde cholangiopancreatography (ERCP) within 12 hours of admission and received oral amoxicillin/clavulanate 875 mg/125 mg and ciprofloxacin 500 mg; they were monitored as inpatients for up to 24 hours following admission. Patients in this group who remained clinically stable with blood cultures negative for pathogenic organisms within the first 24 hours were then randomized.

All patients with acute biliary pancreatitis and an intact gallbladder underwent cholecystectomy within 6 weeks of the pancreatitis episode.

No home-monitored patients required hospitalization in the 5-7 days after discharge, and, as noted before, only one required readmission within 30 days, Dr. Ince said.

He said that the study was limited by the exclusion of alcoholic pancreatitis, which may make the results less applicable to Western nations where alcohol consumption is heavier than in Turkey. He added, however, that acute biliary pancreatitis has overtaken alcoholic pancreatitis in many Western countries, probably because of rising obesity rates.

The study was sponsored by Bezmialem Vakif University. Dr. Ince reported having no financial disclosures.

ORLANDO – Home monitoring of select patients with mild, nonalcoholic acute interstitial pancreatitis is as safe as in-hospital monitoring, at a cost saving of nearly $15,000, according to a study presented at the annual Digestive Disease Week.

In a randomized controlled trial of 84 patients there were no cases of organ failure or pancreatic necrosis and no deaths within 30 days in patients assigned to either home or hospital monitoring. One patient in the home group and two in the hospital group required readmission within 30 days of discharge, reported Dr. Ali T. Ince of the Bezmialem Vakif University Medical Faculty Hospital in Istanbul, Turkey.

The total tab for home monitoring, including emergency department evaluation, intravenous therapy, and nursing visits, was $7,135, compared with $21,960 for in-hospital care, a savings of $14,825.

"Patients with mild nonalcoholic acute pancreatitis can be safely treated at home with regular visits by a nurse. Widespread adoption of this practice could result in large costs savings," Dr. Ince said.

In 2009, acute pancreatitis cases cost the U.S. health care system about $2.6 billion, for a median per patient charge of $6,096.

"The cost of severe acute pancreatitis is more than the cost of mild acute pancreatitis. However, since only 10%-15% of patients have severe acute pancreatitis, the majority of patients admitted have mild disease," he noted.

To see whether home care of such patients could be safely provided, the investigators enrolled patients admitted to the emergency department for evaluation of acute pancreatitis. Those with an Imrie scoring system value of 5 or lower, a Harmless Acute Pancreatitis Score (HAPS) of 2 or less, and a hematocrit of less than 44% were randomly assigned to either home or hospital monitoring, 42 patients in each group. All patients took nothing by mouth initially and had an oral diet gradually reintroduced.

Hospitalized patients were followed for a mean of 5 days. Home-treated patients received nurse visits on the second, third, and fifth day following discharge from the emergency department. At each home visit, nurses took vital signs, assessed symptoms, and evaluated patients’ general condition and transmitted the data to the attending physician. All patients were asked about their complaints and had physical and laboratory exams on day 7, day 14, and day 30.

Patients with organ failure, signs or symptoms of sepsis, alcoholic acute pancreatitis, prior evidence of a dilated pancreatic duct or pancreatic calcifications, coagulopathies, or comorbidities requiring hospitalization were excluded, Dr. Ince said.

All patients in each group were treated with lactated Ringer’s solution 100-150 mL/hour IV for 3 days, parenteral pantoprazole 40 mg/day, intramuscular diclofenac as needed for pain, and parenteral metoclopramide as needed for nausea, he noted.

In addition, those patients with acute biliary pancreatitis and concurrent cholangitis underwent endoscopic retrograde cholangiopancreatography (ERCP) within 12 hours of admission and received oral amoxicillin/clavulanate 875 mg/125 mg and ciprofloxacin 500 mg; they were monitored as inpatients for up to 24 hours following admission. Patients in this group who remained clinically stable with blood cultures negative for pathogenic organisms within the first 24 hours were then randomized.

All patients with acute biliary pancreatitis and an intact gallbladder underwent cholecystectomy within 6 weeks of the pancreatitis episode.

No home-monitored patients required hospitalization in the 5-7 days after discharge, and, as noted before, only one required readmission within 30 days, Dr. Ince said.

He said that the study was limited by the exclusion of alcoholic pancreatitis, which may make the results less applicable to Western nations where alcohol consumption is heavier than in Turkey. He added, however, that acute biliary pancreatitis has overtaken alcoholic pancreatitis in many Western countries, probably because of rising obesity rates.

The study was sponsored by Bezmialem Vakif University. Dr. Ince reported having no financial disclosures.

ORLANDO – Home monitoring of select patients with mild, nonalcoholic acute interstitial pancreatitis is as safe as in-hospital monitoring, at a cost saving of nearly $15,000, according to a study presented at the annual Digestive Disease Week.

In a randomized controlled trial of 84 patients there were no cases of organ failure or pancreatic necrosis and no deaths within 30 days in patients assigned to either home or hospital monitoring. One patient in the home group and two in the hospital group required readmission within 30 days of discharge, reported Dr. Ali T. Ince of the Bezmialem Vakif University Medical Faculty Hospital in Istanbul, Turkey.

The total tab for home monitoring, including emergency department evaluation, intravenous therapy, and nursing visits, was $7,135, compared with $21,960 for in-hospital care, a savings of $14,825.

"Patients with mild nonalcoholic acute pancreatitis can be safely treated at home with regular visits by a nurse. Widespread adoption of this practice could result in large costs savings," Dr. Ince said.

In 2009, acute pancreatitis cases cost the U.S. health care system about $2.6 billion, for a median per patient charge of $6,096.

"The cost of severe acute pancreatitis is more than the cost of mild acute pancreatitis. However, since only 10%-15% of patients have severe acute pancreatitis, the majority of patients admitted have mild disease," he noted.

To see whether home care of such patients could be safely provided, the investigators enrolled patients admitted to the emergency department for evaluation of acute pancreatitis. Those with an Imrie scoring system value of 5 or lower, a Harmless Acute Pancreatitis Score (HAPS) of 2 or less, and a hematocrit of less than 44% were randomly assigned to either home or hospital monitoring, 42 patients in each group. All patients took nothing by mouth initially and had an oral diet gradually reintroduced.

Hospitalized patients were followed for a mean of 5 days. Home-treated patients received nurse visits on the second, third, and fifth day following discharge from the emergency department. At each home visit, nurses took vital signs, assessed symptoms, and evaluated patients’ general condition and transmitted the data to the attending physician. All patients were asked about their complaints and had physical and laboratory exams on day 7, day 14, and day 30.

Patients with organ failure, signs or symptoms of sepsis, alcoholic acute pancreatitis, prior evidence of a dilated pancreatic duct or pancreatic calcifications, coagulopathies, or comorbidities requiring hospitalization were excluded, Dr. Ince said.

All patients in each group were treated with lactated Ringer’s solution 100-150 mL/hour IV for 3 days, parenteral pantoprazole 40 mg/day, intramuscular diclofenac as needed for pain, and parenteral metoclopramide as needed for nausea, he noted.

In addition, those patients with acute biliary pancreatitis and concurrent cholangitis underwent endoscopic retrograde cholangiopancreatography (ERCP) within 12 hours of admission and received oral amoxicillin/clavulanate 875 mg/125 mg and ciprofloxacin 500 mg; they were monitored as inpatients for up to 24 hours following admission. Patients in this group who remained clinically stable with blood cultures negative for pathogenic organisms within the first 24 hours were then randomized.

All patients with acute biliary pancreatitis and an intact gallbladder underwent cholecystectomy within 6 weeks of the pancreatitis episode.

No home-monitored patients required hospitalization in the 5-7 days after discharge, and, as noted before, only one required readmission within 30 days, Dr. Ince said.

He said that the study was limited by the exclusion of alcoholic pancreatitis, which may make the results less applicable to Western nations where alcohol consumption is heavier than in Turkey. He added, however, that acute biliary pancreatitis has overtaken alcoholic pancreatitis in many Western countries, probably because of rising obesity rates.

The study was sponsored by Bezmialem Vakif University. Dr. Ince reported having no financial disclosures.

ORLANDO – Cold snare polypectomy is clearly superior to double biopsy cold forceps polypectomy for the complete removal of small colorectal polyps, according to findings from a single-center, prospective, randomized controlled study involving 54 patients.

The rates of both visual polyp eradication and complete histologic eradication were significantly higher in patients randomized to the cold snare polypectomy (CSP) group than in those randomized to the cold forceps polypectomy (CFP) group (91.5% vs. 78.3%, and 93.2% vs. 75.9%, respectively), Dr. Chang Kyun Lee reported at the annual Digestive Disease Week.

Additional analysis in the CFP group showed a histologic eradication rate of 92% for 1- to 3-mm polyps, and 50% for 4- to 5-mm polyps.

On logistic regression analysis, CFP and polyp size of 4 mm or larger were associated with incomplete polyp eradication (odds ratios 4.75 and 4.38, respectively), whereas lesion location and histologic diagnosis were not, said Dr. Lee of Kyung Hee University, Seoul, Republic of Korea.

The 54 study subjects were adults (mean age, 53.7 years) and a total of 115 1- to 5-mm polyps. Most polyps (88%) were 0-IIa type, and most (70.1%) were tubular adenomas. The mean polyp size was 3.66 mm.

The treatment groups did not differ significantly with respect to sex, age, indication for colonoscopy, or procedure time, and no differences were noted in the size, location, and diagnosis of polyps.

Only one polyp with advanced histologic features was identified. The 5-mm lesion – a tubular adenoma – was located in the proximal colon and was removed completely via CFP.

CSP was performed using a minisnare, and CFP was performed using standard large-capacity forceps and a double biopsy technique (two "bites" per forceps pass). Polyp removal time was significantly shorter with CSP than with CFP (14.29 vs. 22.03 seconds), though this difference was not clinically meaningful. The rate of successful retrieval of polypectomy samples was lower in the CSP group (93.2% vs. 100% for CFP), Dr. Lee noted.

While cold techniques are widely used in clinical practice, few studies have directly compared outcomes with different techniques. These findings indicate that choice of technique is clinically important to the endoscopic removal of diminutive polyps, he said.

"Based on the findings, we recommend that cold snaring be considered as the primary method for endoscopic treatment of polyps in the 4- to 5-mm size range. However, given the incomplete polypectomy rate in this study – about 15% – further technical refinements and instrumental innovations are required for future studies," Dr. Lee concluded.

Dr. Lee reported having no disclosures.

ORLANDO – Cold snare polypectomy is clearly superior to double biopsy cold forceps polypectomy for the complete removal of small colorectal polyps, according to findings from a single-center, prospective, randomized controlled study involving 54 patients.

The rates of both visual polyp eradication and complete histologic eradication were significantly higher in patients randomized to the cold snare polypectomy (CSP) group than in those randomized to the cold forceps polypectomy (CFP) group (91.5% vs. 78.3%, and 93.2% vs. 75.9%, respectively), Dr. Chang Kyun Lee reported at the annual Digestive Disease Week.

Additional analysis in the CFP group showed a histologic eradication rate of 92% for 1- to 3-mm polyps, and 50% for 4- to 5-mm polyps.

On logistic regression analysis, CFP and polyp size of 4 mm or larger were associated with incomplete polyp eradication (odds ratios 4.75 and 4.38, respectively), whereas lesion location and histologic diagnosis were not, said Dr. Lee of Kyung Hee University, Seoul, Republic of Korea.

The 54 study subjects were adults (mean age, 53.7 years) and a total of 115 1- to 5-mm polyps. Most polyps (88%) were 0-IIa type, and most (70.1%) were tubular adenomas. The mean polyp size was 3.66 mm.

The treatment groups did not differ significantly with respect to sex, age, indication for colonoscopy, or procedure time, and no differences were noted in the size, location, and diagnosis of polyps.

Only one polyp with advanced histologic features was identified. The 5-mm lesion – a tubular adenoma – was located in the proximal colon and was removed completely via CFP.

CSP was performed using a minisnare, and CFP was performed using standard large-capacity forceps and a double biopsy technique (two "bites" per forceps pass). Polyp removal time was significantly shorter with CSP than with CFP (14.29 vs. 22.03 seconds), though this difference was not clinically meaningful. The rate of successful retrieval of polypectomy samples was lower in the CSP group (93.2% vs. 100% for CFP), Dr. Lee noted.

While cold techniques are widely used in clinical practice, few studies have directly compared outcomes with different techniques. These findings indicate that choice of technique is clinically important to the endoscopic removal of diminutive polyps, he said.

"Based on the findings, we recommend that cold snaring be considered as the primary method for endoscopic treatment of polyps in the 4- to 5-mm size range. However, given the incomplete polypectomy rate in this study – about 15% – further technical refinements and instrumental innovations are required for future studies," Dr. Lee concluded.

Dr. Lee reported having no disclosures.

ORLANDO – Cold snare polypectomy is clearly superior to double biopsy cold forceps polypectomy for the complete removal of small colorectal polyps, according to findings from a single-center, prospective, randomized controlled study involving 54 patients.

The rates of both visual polyp eradication and complete histologic eradication were significantly higher in patients randomized to the cold snare polypectomy (CSP) group than in those randomized to the cold forceps polypectomy (CFP) group (91.5% vs. 78.3%, and 93.2% vs. 75.9%, respectively), Dr. Chang Kyun Lee reported at the annual Digestive Disease Week.

Additional analysis in the CFP group showed a histologic eradication rate of 92% for 1- to 3-mm polyps, and 50% for 4- to 5-mm polyps.

On logistic regression analysis, CFP and polyp size of 4 mm or larger were associated with incomplete polyp eradication (odds ratios 4.75 and 4.38, respectively), whereas lesion location and histologic diagnosis were not, said Dr. Lee of Kyung Hee University, Seoul, Republic of Korea.

The 54 study subjects were adults (mean age, 53.7 years) and a total of 115 1- to 5-mm polyps. Most polyps (88%) were 0-IIa type, and most (70.1%) were tubular adenomas. The mean polyp size was 3.66 mm.

The treatment groups did not differ significantly with respect to sex, age, indication for colonoscopy, or procedure time, and no differences were noted in the size, location, and diagnosis of polyps.

Only one polyp with advanced histologic features was identified. The 5-mm lesion – a tubular adenoma – was located in the proximal colon and was removed completely via CFP.

CSP was performed using a minisnare, and CFP was performed using standard large-capacity forceps and a double biopsy technique (two "bites" per forceps pass). Polyp removal time was significantly shorter with CSP than with CFP (14.29 vs. 22.03 seconds), though this difference was not clinically meaningful. The rate of successful retrieval of polypectomy samples was lower in the CSP group (93.2% vs. 100% for CFP), Dr. Lee noted.

While cold techniques are widely used in clinical practice, few studies have directly compared outcomes with different techniques. These findings indicate that choice of technique is clinically important to the endoscopic removal of diminutive polyps, he said.

"Based on the findings, we recommend that cold snaring be considered as the primary method for endoscopic treatment of polyps in the 4- to 5-mm size range. However, given the incomplete polypectomy rate in this study – about 15% – further technical refinements and instrumental innovations are required for future studies," Dr. Lee concluded.

Dr. Lee reported having no disclosures.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

In patients with mild to moderate obesity and poorly controlled type 2 diabetes, adding Roux-en-Y gastric bypass surgery to intensive lifestyle and medical management more than doubles the likelihood of achieving weight-loss and metabolic goals within 1 year, according to the results of a randomized trial reported in the June 5 issue of JAMA.

However, this potential benefit must be weighed against what appears to be a moderate risk of serious adverse events, even when the procedure is done by experienced medical teams, said Dr. Sayeed Ikramuddin of the department of surgery, University of Minnesota, Minneapolis, and his associates.

In addition, the permanence of weight loss and metabolic results following the first 1-2 years after the procedure remains uncertain, as do long-term adverse events, because so few studies have adequately followed patients past that point, the investigators wrote.

Dr. Ikramuddin and his colleagues drew these conclusions from their randomized trial of 120 patients with mild to moderate obesity (body mass index, 30.0-39.9 kg/m²) whose type 2 diabetes was poorly controlled on standard medical therapy.

In a separate report in the same issue of JAMA, Dr. Melinda Maggard-Gibbons of the University of California, Los Angeles, and her associates reported their findings from a systematic review of the literature regarding all types of bariatric surgery in similar patients with mild obesity (BMI, 30-35). They found that there still is not sufficient evidence to determine whether bariatric surgery is warranted in this patient population because of the lack of long-term data on safety and efficacy. They identified only four studies with a follow-up of more than 2 years, and those had small sample sizes or poor methodology that "preclude definitive conclusions."

Thus, neither of these investigations can support or refute the suggestion by some proponents that bariatric surgery should be extended to diabetic patients with low-grade obesity to improve their glycemic control.

In their prospective, unblinded clinical trial, Dr. Ikramuddin and his associates offered a free, intensive lifestyle and medical-therapy weight control program to the 120 study subjects at one academic medical center in Minnesota, one in New York, and two in Taiwan over a 3-year period. All patients were between 30 and 67 years of age and had hemoglobin A_1c (HbA_1c) levels of 8% or higher (mean, 9.6%); the average duration of diabetes was 9 years.

The program included daily weigh-ins and detailed diaries of eating and exercise, with caloric intake goals of 1,200-1,800 kcal/day and moderate physical activity for at least 325 min/week to achieve a weight loss of 1-2 pounds/week. The study subjects met regularly with trained interventionists to discuss weight management and to enhance adherence.

Patients could add orlistat or, until it was withdrawn from the market, sibutramine for weight control. Medications for glycemic control were added as necessary, as were aspirin therapy and medications to control cholesterol levels and blood pressure.

Half of the study subjects were then randomly assigned to undergo laparoscopic Roux-en-Y gastric bypass. This group was given multivitamin and mineral supplements.

The endpoint of the study was a triple outcome endorsed by the American Diabetes Association: an HbA_1c level of less than 7%, a low-density lipoprotein (LDL) cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg at 1-year follow-up.

A total of 28 patients (49%) in the gastric bypass group achieved this end point, compared with only 11 (19%) in the lifestyle/medical management group, Dr. Ikramuddin and his colleagues reported (JAMA 2013;309:2240-49).

Of these three components of the combined endpoint, only HbA_1c level showed a significant difference between the two study groups: 43 (75%) of the surgery group achieved an HbA_1c level under 7%, compared with just 18 (32%) of the lifestyle/medical management group.

The difference in outcomes between the two groups was attributed chiefly to their difference in weight loss. The mean loss at 1 year was 26% of baseline weight after gastric bypass, compared with 8% with the intensive lifestyle/medication program.

Patients in the surgery group continued to lose weight throughout the year of follow-up, while those in the other group tended to lose weight during the first 6 months and plateau after that.

On average, at 1 year the patients in the surgery group required three fewer medications than did those in the other group to manage glycemia, dyslipidemia, and hypertension.

However, patients who underwent gastric bypass had 50% more serious adverse events and 55% more nonserious adverse events than did those who did not. "All surgeons performing gastric bypass in this study were experts; thus the occurrence of serious complications must be factored into the design of larger trials of effectiveness for patients with moderate obesity," Dr. Ikramuddin and his associates said.

The 22 serious adverse events in the surgery group included 4 perioperative and 6 late postoperative complications. The most serious complications involved anastomotic leakage that was not detected on routine postoperative upper-GI contrast studies. One of these patients eventually required extracorporeal membrane oxygenation; she developed anoxic brain injury, required lower-extremity amputation, and remains permanently disabled.

Nutritional deficiencies also developed relatively often in the bypass group, despite supplementation. These included iron, vitamin B, and vitamin D deficiencies, as well as hypoalbuminemia.

Other adverse events known to develop more than 1 year after gastric bypass include weight regain, internal hernias, anastomotic ulcers, hypoglycemia, anastomotic strictures, bleeding, bowel obstruction, kidney stones, and fractures.

Overall, these findings show that "the merit of gastric bypass treatment of moderately obese patients with type 2 diabetes depends on whether potential benefits make [these] risks acceptable," the investigators said.

In their systematic review of the literature, Dr. Maggard-Gibbons and her associates reviewed 1,291 studies but could find only 3 randomized trials that came close to directly comparing surgical against nonsurgical interventions in patients with BMIs of 30-35. The total number of patients in these trials was only 290, and individual-level data were available only for 13 patients with type 2 diabetes in this weight category.

They then altered their search criteria to include studies of patients with BMIs of 35-40 and studies that did not directly compare outcomes between surgical and nonsurgical approaches. Even then, "many of the studies were from single surgeons at single academic institutions and may not be representative of results in a general population of patients and surgeons."

Of greatest concern was the fact that "we found no long-term studies of postsurgery adverse events in patients with diabetes within our target BMI range," they said (JAMA 2013;309:2250-61).

The limited studies that were available consistently found that short-term weight loss and glycemic control were better for patients treated with bariatric surgery than for those who were not. However, the durability of these results is uncertain, and the amount of weight loss did not always correlate with the degree of improvement of metabolic factors. And it is not yet known whether these outcomes translate into reduction in the important macrovascular and microvascular effects of diabetes.

Moreover, although surgical complications were not common, those that did occur often were serious and required significant intervention. And of the few studies that did track later complications, most were not designed to do so and covered only "surgeon-reported outcomes from selected, experienced centers."

Thus, "the evidence is insufficient to reach conclusions about the appropriate use of bariatric surgery in this patient population, [and] performance of these procedures in this target population should be under close scientific scrutiny," Dr. Maggard-Gibbons and her colleagues said.

Dr. Irkamuddin’s study was supported by Covidien and the National Center for Advancing Translational Sciences. Dr. Irkamuddin reported ties to Novo Nordisk, USGI, and other companies; his associates reported ties to numerous industry sources. Dr. Maggard-Gibbons’ study was supported by the Agency for Healthcare Research and Quality; she and her associates reported no relevant financial conflicts of interest.

ORLANDO – Researchers have identified a novel genetic marker for increased pancreatic cancer risk.

The marker, a single nucleotide polymorphism (SNP) of the cholecystokinin-B (CCK-B) receptor, could serve as a screening test for high-risk subjects, Dr. Jill P. Smith reported at the annual Digestive Disease Week.

The CCK-B receptor is a G-protein coupled receptor through which the effects of the peptide gastrin – which regulates pancreatic cancer growth – are mediated. Both gastrin and the CCK-B receptor are overexpressed in pancreatic cancer.

Dr. Smith and her colleagues discovered a splice variant of the CCK-B receptor, known as the CCK-C receptor, which results from retention of the fourth intron on the CCK-B receptor and the insertion of 69 amino acids to the third intracellular loop, she explained.

This change increases the affinity to gastrin and is associated with a more aggressive pancreatic cancer phenotype.

"So we hypothesized that the missplicing of the fourth intron of the CCK-B receptor was the result of a genetic mutation. We also felt that the translation of the additional 69 amino acids in the third intracellular loop of the CCK-B receptor would then contribute to the aggressive phenotype that we know of as pancreatic cancer," said Dr. Smith of the National Institutes of Health.

The investigators analyzed DNA extracted from blood or surgical cancer tissue specimens of 962 pancreatic cancer patients with ductal adenocarcinoma who were treated at three major medical centers, as well as from samples of normal pancreas tissue. The analysis confirmed that the etiology of the misspliced receptor was due to a SNP (involving a transition from C to A) at position 32 of the fourth intron that corresponded to the known SNP rs1800843. The newly identified SNP was not previously identified in genomewide association studies due to its location within an intron, rather than an exon, she noted.

The frequency of the A allele was significantly greater among those with pancreatic cancer than among controls (odds ratio, 1.57).

In addition, survival was significantly reduced in subjects who had the A allele (either AA or AC), compared with subjects with the CC genotype: Survival was about 14 months for patients with AA and 17 months for those with AC, compared with nearly 20 months for CC, Dr. Smith said.

The reduced survival was not a result of more advanced disease state at diagnosis, as the mean stage of subjects with two A alleles (AA) was slightly lower than in those with the CC genotype, she noted.

The findings are notable given that survival from pancreatic cancer has not improved over the past several decades, and that no test exists to diagnose pancreatic cancer in the early stages; more than 90% of patients have advanced disease at the time of diagnosis. Also, no screening tests without radiation are available for high-risk patients, Dr. Smith said.

"The finding of a germline mutation linked to a phenotype that’s significantly increased in patients with pancreatic cancer makes the CCK-B receptor relevant for clinical screening in high-risk subjects or families. Use of this new genetic marker may lead to early detection or even prevention of pancreatic cancer," she concluded.

This study was supported by a National Institutes of Health grant. Dr. Smith disclosed that she is a TNI Biotech stock shareholder.

ORLANDO – Researchers have identified a novel genetic marker for increased pancreatic cancer risk.

The marker, a single nucleotide polymorphism (SNP) of the cholecystokinin-B (CCK-B) receptor, could serve as a screening test for high-risk subjects, Dr. Jill P. Smith reported at the annual Digestive Disease Week.

The CCK-B receptor is a G-protein coupled receptor through which the effects of the peptide gastrin – which regulates pancreatic cancer growth – are mediated. Both gastrin and the CCK-B receptor are overexpressed in pancreatic cancer.

Dr. Smith and her colleagues discovered a splice variant of the CCK-B receptor, known as the CCK-C receptor, which results from retention of the fourth intron on the CCK-B receptor and the insertion of 69 amino acids to the third intracellular loop, she explained.

This change increases the affinity to gastrin and is associated with a more aggressive pancreatic cancer phenotype.

"So we hypothesized that the missplicing of the fourth intron of the CCK-B receptor was the result of a genetic mutation. We also felt that the translation of the additional 69 amino acids in the third intracellular loop of the CCK-B receptor would then contribute to the aggressive phenotype that we know of as pancreatic cancer," said Dr. Smith of the National Institutes of Health.

The investigators analyzed DNA extracted from blood or surgical cancer tissue specimens of 962 pancreatic cancer patients with ductal adenocarcinoma who were treated at three major medical centers, as well as from samples of normal pancreas tissue. The analysis confirmed that the etiology of the misspliced receptor was due to a SNP (involving a transition from C to A) at position 32 of the fourth intron that corresponded to the known SNP rs1800843. The newly identified SNP was not previously identified in genomewide association studies due to its location within an intron, rather than an exon, she noted.

The frequency of the A allele was significantly greater among those with pancreatic cancer than among controls (odds ratio, 1.57).

In addition, survival was significantly reduced in subjects who had the A allele (either AA or AC), compared with subjects with the CC genotype: Survival was about 14 months for patients with AA and 17 months for those with AC, compared with nearly 20 months for CC, Dr. Smith said.

The reduced survival was not a result of more advanced disease state at diagnosis, as the mean stage of subjects with two A alleles (AA) was slightly lower than in those with the CC genotype, she noted.

The findings are notable given that survival from pancreatic cancer has not improved over the past several decades, and that no test exists to diagnose pancreatic cancer in the early stages; more than 90% of patients have advanced disease at the time of diagnosis. Also, no screening tests without radiation are available for high-risk patients, Dr. Smith said.

"The finding of a germline mutation linked to a phenotype that’s significantly increased in patients with pancreatic cancer makes the CCK-B receptor relevant for clinical screening in high-risk subjects or families. Use of this new genetic marker may lead to early detection or even prevention of pancreatic cancer," she concluded.

This study was supported by a National Institutes of Health grant. Dr. Smith disclosed that she is a TNI Biotech stock shareholder.

ORLANDO – Researchers have identified a novel genetic marker for increased pancreatic cancer risk.

The marker, a single nucleotide polymorphism (SNP) of the cholecystokinin-B (CCK-B) receptor, could serve as a screening test for high-risk subjects, Dr. Jill P. Smith reported at the annual Digestive Disease Week.

The CCK-B receptor is a G-protein coupled receptor through which the effects of the peptide gastrin – which regulates pancreatic cancer growth – are mediated. Both gastrin and the CCK-B receptor are overexpressed in pancreatic cancer.

Dr. Smith and her colleagues discovered a splice variant of the CCK-B receptor, known as the CCK-C receptor, which results from retention of the fourth intron on the CCK-B receptor and the insertion of 69 amino acids to the third intracellular loop, she explained.

This change increases the affinity to gastrin and is associated with a more aggressive pancreatic cancer phenotype.

"So we hypothesized that the missplicing of the fourth intron of the CCK-B receptor was the result of a genetic mutation. We also felt that the translation of the additional 69 amino acids in the third intracellular loop of the CCK-B receptor would then contribute to the aggressive phenotype that we know of as pancreatic cancer," said Dr. Smith of the National Institutes of Health.

The investigators analyzed DNA extracted from blood or surgical cancer tissue specimens of 962 pancreatic cancer patients with ductal adenocarcinoma who were treated at three major medical centers, as well as from samples of normal pancreas tissue. The analysis confirmed that the etiology of the misspliced receptor was due to a SNP (involving a transition from C to A) at position 32 of the fourth intron that corresponded to the known SNP rs1800843. The newly identified SNP was not previously identified in genomewide association studies due to its location within an intron, rather than an exon, she noted.

The frequency of the A allele was significantly greater among those with pancreatic cancer than among controls (odds ratio, 1.57).

In addition, survival was significantly reduced in subjects who had the A allele (either AA or AC), compared with subjects with the CC genotype: Survival was about 14 months for patients with AA and 17 months for those with AC, compared with nearly 20 months for CC, Dr. Smith said.

The reduced survival was not a result of more advanced disease state at diagnosis, as the mean stage of subjects with two A alleles (AA) was slightly lower than in those with the CC genotype, she noted.

The findings are notable given that survival from pancreatic cancer has not improved over the past several decades, and that no test exists to diagnose pancreatic cancer in the early stages; more than 90% of patients have advanced disease at the time of diagnosis. Also, no screening tests without radiation are available for high-risk patients, Dr. Smith said.

"The finding of a germline mutation linked to a phenotype that’s significantly increased in patients with pancreatic cancer makes the CCK-B receptor relevant for clinical screening in high-risk subjects or families. Use of this new genetic marker may lead to early detection or even prevention of pancreatic cancer," she concluded.

This study was supported by a National Institutes of Health grant. Dr. Smith disclosed that she is a TNI Biotech stock shareholder.

ORLANDO – Having a cytopathologist on hand during an ultrasound-guided biopsy of the pancreas can increase the likelihood of getting it right on the first try, according to results from a randomized controlled trial reported at the annual Digestive Disease Week.

Among 131 patients at three clinical centers who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses, those randomized to procedures with on-site cytopathology (CyP+) had a significantly higher proportion of biopsies deemed suspicious or malignant than did those randomized to biopsies with no cytopathologist immediately at hand.

Patients with on-site cytopathology also were significantly more likely to have adequate specimens taken, and to require fewer EUS-FNA passes per procedure, reported Dr. Sachin Wani, of the University of Colorado Anschutz Medical Center in Aurora, and his colleagues.

Biopsies performed with cytopathologists present took about 4 minutes longer to perform, however.

Investigators in three tertiary care centers in Missouri and Colorado randomly assigned patients with pancreatic masses to undergo EUS-FNA with cytopathology on-site, with the number of needle passes determined by the judgment of the adequacy of the sample by the pathologist (maximum of 10) or the same procedure with 7 passes, with cytopathology performed later.

At each center, all final pathology slides were reviewed by cytopathologists using standard criteria for both cytologic characteristics and final cytologic diagnosis.

Cytologic criteria include adequacy of the sample, amount of blood, cellularity, and contamination. The final diagnosis categories were benign, atypical, suspicious, malignant, or inadequate.

Although more patients in the CyP+ group were diagnosed with a malignancy (80.3% vs. 67.7%), this difference was not significant. However, when samples deemed to be suspicious were included, on-site cytopathologists identified significantly more samples than pathologists who examined samples after the fact (87.9% vs. 70.8%; P = .01).

In addition, more patients in the CyP+ group had adequate specimens (93.9% vs. 81.5%; P = .03), and these specimens were acquired with significantly fewer median needle passes (three vs. seven; P less than .001).

CyP+ biopsies took an average of 23.4 minutes, compared with 19.1 minutes for biopsies with later pathology review (P = .04). But the time to review slides was significantly shorter when the cytopathologist was present (16.4 vs. 27.7 minutes; P less than .001).

Dr. Wani noted that his presentation was based on an interim analysis of an ongoing study, and that pathology readings were left to the individual treatment centers, with no central pathology performed.

The study was supported by a clinical research award from the American College of Gastroenterology. Dr. Wani reported having no financial disclosures.

ORLANDO – Having a cytopathologist on hand during an ultrasound-guided biopsy of the pancreas can increase the likelihood of getting it right on the first try, according to results from a randomized controlled trial reported at the annual Digestive Disease Week.

Among 131 patients at three clinical centers who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses, those randomized to procedures with on-site cytopathology (CyP+) had a significantly higher proportion of biopsies deemed suspicious or malignant than did those randomized to biopsies with no cytopathologist immediately at hand.

Patients with on-site cytopathology also were significantly more likely to have adequate specimens taken, and to require fewer EUS-FNA passes per procedure, reported Dr. Sachin Wani, of the University of Colorado Anschutz Medical Center in Aurora, and his colleagues.

Biopsies performed with cytopathologists present took about 4 minutes longer to perform, however.

Investigators in three tertiary care centers in Missouri and Colorado randomly assigned patients with pancreatic masses to undergo EUS-FNA with cytopathology on-site, with the number of needle passes determined by the judgment of the adequacy of the sample by the pathologist (maximum of 10) or the same procedure with 7 passes, with cytopathology performed later.

At each center, all final pathology slides were reviewed by cytopathologists using standard criteria for both cytologic characteristics and final cytologic diagnosis.

Cytologic criteria include adequacy of the sample, amount of blood, cellularity, and contamination. The final diagnosis categories were benign, atypical, suspicious, malignant, or inadequate.

Although more patients in the CyP+ group were diagnosed with a malignancy (80.3% vs. 67.7%), this difference was not significant. However, when samples deemed to be suspicious were included, on-site cytopathologists identified significantly more samples than pathologists who examined samples after the fact (87.9% vs. 70.8%; P = .01).

In addition, more patients in the CyP+ group had adequate specimens (93.9% vs. 81.5%; P = .03), and these specimens were acquired with significantly fewer median needle passes (three vs. seven; P less than .001).

CyP+ biopsies took an average of 23.4 minutes, compared with 19.1 minutes for biopsies with later pathology review (P = .04). But the time to review slides was significantly shorter when the cytopathologist was present (16.4 vs. 27.7 minutes; P less than .001).

Dr. Wani noted that his presentation was based on an interim analysis of an ongoing study, and that pathology readings were left to the individual treatment centers, with no central pathology performed.

The study was supported by a clinical research award from the American College of Gastroenterology. Dr. Wani reported having no financial disclosures.

ORLANDO – Having a cytopathologist on hand during an ultrasound-guided biopsy of the pancreas can increase the likelihood of getting it right on the first try, according to results from a randomized controlled trial reported at the annual Digestive Disease Week.

Among 131 patients at three clinical centers who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic masses, those randomized to procedures with on-site cytopathology (CyP+) had a significantly higher proportion of biopsies deemed suspicious or malignant than did those randomized to biopsies with no cytopathologist immediately at hand.

Patients with on-site cytopathology also were significantly more likely to have adequate specimens taken, and to require fewer EUS-FNA passes per procedure, reported Dr. Sachin Wani, of the University of Colorado Anschutz Medical Center in Aurora, and his colleagues.

Biopsies performed with cytopathologists present took about 4 minutes longer to perform, however.

Investigators in three tertiary care centers in Missouri and Colorado randomly assigned patients with pancreatic masses to undergo EUS-FNA with cytopathology on-site, with the number of needle passes determined by the judgment of the adequacy of the sample by the pathologist (maximum of 10) or the same procedure with 7 passes, with cytopathology performed later.

At each center, all final pathology slides were reviewed by cytopathologists using standard criteria for both cytologic characteristics and final cytologic diagnosis.

Cytologic criteria include adequacy of the sample, amount of blood, cellularity, and contamination. The final diagnosis categories were benign, atypical, suspicious, malignant, or inadequate.

Although more patients in the CyP+ group were diagnosed with a malignancy (80.3% vs. 67.7%), this difference was not significant. However, when samples deemed to be suspicious were included, on-site cytopathologists identified significantly more samples than pathologists who examined samples after the fact (87.9% vs. 70.8%; P = .01).

In addition, more patients in the CyP+ group had adequate specimens (93.9% vs. 81.5%; P = .03), and these specimens were acquired with significantly fewer median needle passes (three vs. seven; P less than .001).

CyP+ biopsies took an average of 23.4 minutes, compared with 19.1 minutes for biopsies with later pathology review (P = .04). But the time to review slides was significantly shorter when the cytopathologist was present (16.4 vs. 27.7 minutes; P less than .001).

Dr. Wani noted that his presentation was based on an interim analysis of an ongoing study, and that pathology readings were left to the individual treatment centers, with no central pathology performed.

The study was supported by a clinical research award from the American College of Gastroenterology. Dr. Wani reported having no financial disclosures.