Endoscopy, Pancreas, & Biliary Tract

ORLANDO – Adding celecoxib to octreotide within 48 hours of onset of acute pancreatitis may reduce the risk of progression to severe acute disease and its consequences, based on data from a randomized controlled trial of more than 300 patients.

The findings were presented at the annual Digestive Disease Week.

Overall, 25.6% of patients predicted to progress to severe acute pancreatitis (SAP) who were assigned to octreotide (Sandostatin) alone had organ failure at day 8, compared with 12.9% who received both octreotide and celecoxib (Celebrex), reported Dr. Rui Wang of West China Hospital, Sichuan University, in Chengdu, China.

In addition, 36.7% of patients on octreotide-only had CT severity index (CTSI) scores of 6 or greater at day 8, compared with 15.1% of patients on octreotide and celecoxib combined.

"Celecoxib exerted special effects on reducing incidences of pulmonary failure, acute respiratory distress syndrome, and encephalopathy," Dr. Wang said.

Dr. Wang and colleagues hypothesized that celecoxib may decrease serum levels of the inflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor–alpha (TNF-alpha), and increase levels of the anti-inflammatory interleukin-10 (IL-10).

To see whether celecoxib could augment the anti-inflammatory action of octreotide, an analogue of the endogenous anti-inflammatory peptide somatostatin, the investigators conducted a study of high-dose octreotide and somatostatin in patients with predicted or actual SAP.

They enrolled 195 patients with predicted SAP, defined as an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 8, and a multiorgan failure (MOF) score lower than 2; and 159 patients with SAP, defined as an APACHE II score greater than 8 and a MOF score of 2 or greater.

Patients in each disease category were randomized within 48 hours to receive either octreotide alone in an IV infusion at 50 mcg/hour for 3 days, and then 25 mcg/hour for 4 days, or to the same 7-day octreotide regimen plus 200 mg of oral celecoxib twice daily.

Patients with predicted SAP who received the combination had less than half the rate of progression to SAP (P = .001) and half the rate of organ failure (P = .030).

Among patients with frank SAP, there were no significant differences between octreotide alone and octreotide/celecoxib for organ failure, local complications, CTSI or MOF scores, or length of hospital stay, the researchers noted.

Compared with octreotide alone, the addition of celecoxib significantly reduced day 8 rates of acute respiratory distress syndrome (ARDS) (24% vs. 11%, respectively; P = .037), and encephalopathy (16% vs. 5.5%; P = .039).

With regard to the secondary outcome of plasma cytokine levels, the researchers found that octreotide alone or combined with celecoxib similarly restored somatostatin levels to normal by day 8.

The investigators also found that the combination therapy, but not octreotide alone, normalized plasma levels of both IL-6 and TNF-alpha (P less than .05 over baseline), and that IL-10 levels were markedly increased in both groups, although the combination treatment significantly outperformed octreotide-only (P less than .05).

The findings suggest that early treatment with a combination of octreotide and celecoxib may prevent progression to SAP and also ameliorate both ARDS and encephalopathy through simultaneous down-regulation of inflammatory cytokines and promotion of the anti-inflammatory IL-10, the researchers noted.

The funding source was not disclosed. Dr. Wang and colleagues reported having no financial disclosures.

ORLANDO – Adding celecoxib to octreotide within 48 hours of onset of acute pancreatitis may reduce the risk of progression to severe acute disease and its consequences, based on data from a randomized controlled trial of more than 300 patients.

The findings were presented at the annual Digestive Disease Week.

Overall, 25.6% of patients predicted to progress to severe acute pancreatitis (SAP) who were assigned to octreotide (Sandostatin) alone had organ failure at day 8, compared with 12.9% who received both octreotide and celecoxib (Celebrex), reported Dr. Rui Wang of West China Hospital, Sichuan University, in Chengdu, China.

In addition, 36.7% of patients on octreotide-only had CT severity index (CTSI) scores of 6 or greater at day 8, compared with 15.1% of patients on octreotide and celecoxib combined.

"Celecoxib exerted special effects on reducing incidences of pulmonary failure, acute respiratory distress syndrome, and encephalopathy," Dr. Wang said.

Dr. Wang and colleagues hypothesized that celecoxib may decrease serum levels of the inflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor–alpha (TNF-alpha), and increase levels of the anti-inflammatory interleukin-10 (IL-10).

To see whether celecoxib could augment the anti-inflammatory action of octreotide, an analogue of the endogenous anti-inflammatory peptide somatostatin, the investigators conducted a study of high-dose octreotide and somatostatin in patients with predicted or actual SAP.

They enrolled 195 patients with predicted SAP, defined as an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 8, and a multiorgan failure (MOF) score lower than 2; and 159 patients with SAP, defined as an APACHE II score greater than 8 and a MOF score of 2 or greater.

Patients in each disease category were randomized within 48 hours to receive either octreotide alone in an IV infusion at 50 mcg/hour for 3 days, and then 25 mcg/hour for 4 days, or to the same 7-day octreotide regimen plus 200 mg of oral celecoxib twice daily.

Patients with predicted SAP who received the combination had less than half the rate of progression to SAP (P = .001) and half the rate of organ failure (P = .030).

Among patients with frank SAP, there were no significant differences between octreotide alone and octreotide/celecoxib for organ failure, local complications, CTSI or MOF scores, or length of hospital stay, the researchers noted.

Compared with octreotide alone, the addition of celecoxib significantly reduced day 8 rates of acute respiratory distress syndrome (ARDS) (24% vs. 11%, respectively; P = .037), and encephalopathy (16% vs. 5.5%; P = .039).

With regard to the secondary outcome of plasma cytokine levels, the researchers found that octreotide alone or combined with celecoxib similarly restored somatostatin levels to normal by day 8.

The investigators also found that the combination therapy, but not octreotide alone, normalized plasma levels of both IL-6 and TNF-alpha (P less than .05 over baseline), and that IL-10 levels were markedly increased in both groups, although the combination treatment significantly outperformed octreotide-only (P less than .05).

The findings suggest that early treatment with a combination of octreotide and celecoxib may prevent progression to SAP and also ameliorate both ARDS and encephalopathy through simultaneous down-regulation of inflammatory cytokines and promotion of the anti-inflammatory IL-10, the researchers noted.

The funding source was not disclosed. Dr. Wang and colleagues reported having no financial disclosures.

ORLANDO – Adding celecoxib to octreotide within 48 hours of onset of acute pancreatitis may reduce the risk of progression to severe acute disease and its consequences, based on data from a randomized controlled trial of more than 300 patients.

The findings were presented at the annual Digestive Disease Week.

Overall, 25.6% of patients predicted to progress to severe acute pancreatitis (SAP) who were assigned to octreotide (Sandostatin) alone had organ failure at day 8, compared with 12.9% who received both octreotide and celecoxib (Celebrex), reported Dr. Rui Wang of West China Hospital, Sichuan University, in Chengdu, China.

In addition, 36.7% of patients on octreotide-only had CT severity index (CTSI) scores of 6 or greater at day 8, compared with 15.1% of patients on octreotide and celecoxib combined.

"Celecoxib exerted special effects on reducing incidences of pulmonary failure, acute respiratory distress syndrome, and encephalopathy," Dr. Wang said.

Dr. Wang and colleagues hypothesized that celecoxib may decrease serum levels of the inflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor–alpha (TNF-alpha), and increase levels of the anti-inflammatory interleukin-10 (IL-10).

To see whether celecoxib could augment the anti-inflammatory action of octreotide, an analogue of the endogenous anti-inflammatory peptide somatostatin, the investigators conducted a study of high-dose octreotide and somatostatin in patients with predicted or actual SAP.

They enrolled 195 patients with predicted SAP, defined as an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 8, and a multiorgan failure (MOF) score lower than 2; and 159 patients with SAP, defined as an APACHE II score greater than 8 and a MOF score of 2 or greater.

Patients in each disease category were randomized within 48 hours to receive either octreotide alone in an IV infusion at 50 mcg/hour for 3 days, and then 25 mcg/hour for 4 days, or to the same 7-day octreotide regimen plus 200 mg of oral celecoxib twice daily.

Patients with predicted SAP who received the combination had less than half the rate of progression to SAP (P = .001) and half the rate of organ failure (P = .030).

Among patients with frank SAP, there were no significant differences between octreotide alone and octreotide/celecoxib for organ failure, local complications, CTSI or MOF scores, or length of hospital stay, the researchers noted.

Compared with octreotide alone, the addition of celecoxib significantly reduced day 8 rates of acute respiratory distress syndrome (ARDS) (24% vs. 11%, respectively; P = .037), and encephalopathy (16% vs. 5.5%; P = .039).

With regard to the secondary outcome of plasma cytokine levels, the researchers found that octreotide alone or combined with celecoxib similarly restored somatostatin levels to normal by day 8.

The investigators also found that the combination therapy, but not octreotide alone, normalized plasma levels of both IL-6 and TNF-alpha (P less than .05 over baseline), and that IL-10 levels were markedly increased in both groups, although the combination treatment significantly outperformed octreotide-only (P less than .05).

The findings suggest that early treatment with a combination of octreotide and celecoxib may prevent progression to SAP and also ameliorate both ARDS and encephalopathy through simultaneous down-regulation of inflammatory cytokines and promotion of the anti-inflammatory IL-10, the researchers noted.

The funding source was not disclosed. Dr. Wang and colleagues reported having no financial disclosures.

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.

In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.

For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.

In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.

In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.

Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).

The differences were highly statistically significant, Dr. Gralnek said.

Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.

Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.

Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.

The study was sponsored by EndoChoice.

Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.

ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.

In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.

For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.

In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.

In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.

Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).

The differences were highly statistically significant, Dr. Gralnek said.

Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.

Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.

Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.

The study was sponsored by EndoChoice.

Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.

ORLANDO – Use of a novel colonoscope that offers 330-degree viewing, as compared to the 140- to 170-degree viewing of traditional forward-viewing colonoscopes, was associated with a 71% improvement in adenoma detection, according to late-breaking data from a randomized, prospective multicenter study reported at the annual Digestive Disease Week.

In addition to its expanded viewing capability, the device has the same technical features as traditional colonoscopes, including scope length and diameter, full tip deflection, working channel, suction, and forward water-jet irrigation, reported Dr. Ian M. Gralnek of the Technion-Israel Institute of Technology and Elisha Hospital, both in Haifa, Israel.

For the study, 185 patients underwent colonoscopies via both traditional forward-viewing and EndoChoice’s full-spectrum endoscopy (FUSE) colonoscopy in random order on the same day. The overall polyp detection rate was 52.5%, and the adenoma detection rate was 31.7%.

In 88 subjects who underwent traditional colonoscopy followed by FUSE colonoscopy, traditional colonoscopy detected 28 adenomas and the subsequent FUSE colonoscopy detected an additional 20 adenomas, for a 71.4% increase in adenomas found with subsequent FUSE colonoscopy.

In 97 subjects who were randomly assigned to receive FUSE colonoscopy first, 59 adenomas and 2 cancers were detected. On subsequent traditional colonoscopy, 5 additional adenomas were found, yielding an 8.2% increase in adenomas found with subsequent traditional colonoscopy.

Thus, significantly more adenomas were detected by FUSE colonoscopy than with traditional colonoscopy (71.4% vs. 8.2% incremental detection rates), and significantly fewer adenomas were missed by FUSE colonoscopy as compared with traditional colonoscopy (7.6% vs. 42%).

The differences were highly statistically significant, Dr. Gralnek said.

Study subjects were adults aged 18-70 years who were referred between January 2012 and March 2013 for colorectal cancer screening, polyp surveillance, or diagnostic evaluation to one of three sites in Israel, one site in the Netherlands, or two in the United States. Subjects were randomly assigned to receive FUSE or traditional colonoscopy, then to receive the alternative modality on the same day. The same endoscopist performed both examinations.

Though the study findings are limited by the lack of blinding, the fact that the same endoscopist performed both colonoscopies in each patient, and the lack of per-patient analysis, the results highlight the value of the improved visualization afforded by the FUSE colonoscope, Dr. Gralnek concluded.

Developed by EndoChoice, the FUSE colonoscope has a CE marking in Europe, and it recently received 510(k) marketing approval from the U.S. Food and Drug Administration. Commercial availability is expected as early as summer 2013.

The study was sponsored by EndoChoice.

Dr. Gralnek is a member of advisory committees or review panels for Given Imaging and Motus GI, and is a consultant for Given Imaging, Peer Medical, and AstraZeneca.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.

Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.

The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.

"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.

In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.

Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.

Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.

On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.

Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.

Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.

ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.

Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.

The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.

"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.

In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.

Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.

Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.

On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.

Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.

Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.

ORLANDO – Narrow-band imaging colonoscopy accurately predicts the histology of most diminutive polyps in the distal colon, according to findings from a multicenter prospective study.

Use of the technology, which has been promoted as a method for differentiating hypoplastic and adenomatous polyps, could reduce the costs associated with pathological examinations and polypectomy by 60% and 33%, respectively, Dr. Alessandro Repici reported at the annual Digestive Disease Week.

The findings suggest that narrow-band imaging colonoscopy allows high-confidence prediction of the histology of some polyps smaller than 5 mm and is ready for prime time, Dr. Repici said.

"According to our study, high-confidence narrow-band imaging characterization of polyps less than 5 mm was able to meet the criteria threshold for incorporating this kind of real-time histology analysis in clinical practice. This may result in significant reduction of costs in terms of reduction of polypectomy and pathology assessment, and we believe that, according to the present study, high-confidence narrow-band imaging prediction of diminutive polyps located in the distal colon appears ready to be incorporated in clinical practice," he said.

In 278 consecutive patients undergoing elective colonoscopy, a total of 574 polyps smaller than 10 mm, including 429 polyps smaller than 5 mm, were retrieved for histological analysis and were assigned a designation of high or low confidence; 60% of the diminutive polyps were adenomatous. Narrow-band imaging had a sensitivity of 90%, a specificity of 88%, a positive predictive value of 89%, a negative predictive value of 89% and an accuracy of 89% for high-confidence prediction of adenomatous histology in lesions smaller than 5 mm, said Dr. Repici of Istituto Clinico Humanitas, Milan.

Overall, narrow-band imaging had an 84% negative predictive value for diminutive polyps, but the negative predictive value was 92% for those in the distal colon. This met the 90% threshold established by the American Society for Gastrointestinal Endoscopy for adequacy, he said.

Furthermore, high-confidence characterization of polyps smaller than 5 mm predicted the correct surveillance interval in 92% and 99% of cases by American and European guidelines, respectively, he said.

On multivariate analysis, the only independent predictor of an incorrect characterization of polyp histology by narrow-band imaging was a low level of confidence (odds ratio, 3.8), Dr. Repici said.

Study subjects were adults with a mean age of 63 years who underwent elective colonoscopy between May 2011 and May 2012. More than half (58%) were men, and 22% had a family history of colorectal cancer. Participating endoscopists were required to pass a qualifying examination before the start of the study.

Dr. Repici has served on advisory committees or review panels for Boston Scientific and Almirall Prodesfarma, and has served as a consultant for Cosmo Technologies. He has received grant and/or research or other support from Ferring Pharmaceuticals, Olympus Europe, US Endoscopy, and Cook.

Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.

Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.

s-photo/iStockphoto.com

The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.

The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.

Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.

The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.

The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.

Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.

These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.

"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."

Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.

As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.

"But I won’t discourage it by any means," he said.

This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.

Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.

Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.

s-photo/iStockphoto.com

The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.

The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.

Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.

The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.

The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.

Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.

These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.

"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."

Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.

As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.

"But I won’t discourage it by any means," he said.

This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.

Coffee consumption appears to protect against the development of primary sclerosing cholangitis, but not against the development of primary biliary cirrhosis, according to findings from a case-control study involving more than 1,300 subjects.

Average coffee consumption was 50 cups per month among 348 study subjects with primary sclerosing cholangitis (PSC), and those subjects spent an average of 50% of their life actively drinking coffee. Average coffee consumption among 456 healthy controls was 78 cups per month, and those subjects spent an average of 67% of their life actively drinking coffee, Dr. Craig Lammert reported during a press briefing held prior to the annual Digestive Disease Week where the findings will be presented.

s-photo/iStockphoto.com

The differences between the PSC patients and the controls were statistically significant after adjustment for age and sex, said Dr. Lammert of Mayo Clinic, Rochester, Minn.

The healthy controls and 530 subjects with primary biliary cirrhosis (PBC) did not differ significantly with respect to mean age when coffee drinking began, estimated lifetime cups of coffee per month, or percent of life spent actively drinking coffee.

Study subjects were adult patients with well-defined PBC and PSC, and healthy controls recruited between 2002 and 2013. All completed a questionnaire about their coffee drinking history and status.

The PBC patients and healthy controls differed in terms of sex (89% vs. 74% in the groups, respectively, were women), but were of similar age (66 years in both groups). The groups did not differ in terms of the percentages of current coffee drinkers and never coffee drinkers.

The PSC patient and healthy control groups differed significantly both in terms of sex composition and age (57 vs. 66 years, in the groups, respectively). Furthermore, 21% of PSC patients, compared with 13% of controls, reported never drinking coffee, and 67% of PSC patients, compared with 78% of controls, were current coffee drinkers. These differences were significant even after adjustment for age and sex.

Coffee consumption has been linked with numerous health benefits, including protective effects in the liver, but detailed evaluation of coffee use among patients with cholestatic liver disease has been lacking, according to Dr. Lammert.

These findings reveal an environmental effect divergence between PSC and PBC, which is interesting given that coffee was previously thought to be protective in advanced liver disease, said Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass.

"The key question to answer is, why is PBC different?" he asked, adding that PBC appears to be an "outlier that doesn’t follow the model or patterns reported to date."

Indeed, the findings are expected to spur new research into the environmental factors associated with complex liver disease, Dr. Lammert said.

As for whether patients with PSC should be encouraged to drink coffee, Dr. Lammert said the data are insufficient for making specific recommendations at this point.

"But I won’t discourage it by any means," he said.

This study was funded by grants from the National Institutes of Health and the American Liver Foundation. Dr. Lammert reported having no disclosures.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

Concentrations of certain exhaled volatile organic compounds are significantly higher in obese children than in nonobese children, according to findings from a controlled study involving more than 100 children.

The findings could lead to improved understanding of the pathophysiologic processes and pathways leading to childhood obesity, according to Dr. Naim Alkhouri of Cleveland Clinic Children’s Hospital.

These "breath prints" also could lead to interventions for childhood obesity, Dr. Alkhouri said at a press briefing held in advance of the annual Digestive Disease Week, where the data will be presented.

Mass spectrometry in 60 obese children and 55 lean controls demonstrated differences in the concentrations of more than 50 volatile organic compounds (VOCs). Four ion peaks were shown to identify overweight/obese subjects with 92% accuracy, he said.

Further analysis showed significantly higher concentrations of four VOCs in the obese vs. nonobese children after adjustment for age, height, and race. These included breath isoprene (11.6 ppb vs. 6.2 ppb), 1-octene (7.7 ppb vs. 4.6 ppb), ammonia (67.4 ppb vs. 50.1 ppb), and hydrogen sulfide (0.49 vs. 0.35 ppb), he said.

Overweight and obese study subjects were children recruited from a pediatric preventive cardiology and metabolic clinic; healthy controls were recruited from a general pediatric clinic during well-child visits. All underwent a single exhaled breath collection using selective ion flow tube-mass spectrometry.

The obese and lean groups differed significantly in that those in the obese group were older (mean of 14.1 vs. 12.1 years), taller (mean of 164.9 vs. 153.3 cm), and more likely to be white (60% vs. 35.2%).

"Obesity continues to be an epidemic in the United States and worldwide. We estimate that 17% of children in the United States are obese, and 32% percent are overweight," Dr. Alkhouri said, adding that these children are at risk for serious health complications, such as diabetes, obstructive sleep apnea, nonalcoholic fatty liver disease, and cardiovascular disease.

"We believe that these breath prints will shed light on the causes and complications of childhood obesity. This could have implications for early interventions as well as new and easier ways to screen for obesity-related complications," he concluded.

Dr. Alkhouri disclosed ties with Gilead Sciences, Vertex Pharmaceuticals, and Merck.

An investigational serum biomarker panel accurately identified potentially resectable cases of pancreatic cancer, opening up the possibility that a blood test could identify the cancer early and improve its dismal prognosis.

The panel measured four metabolites and had an overall sensitivity of 71% and a specificity of 78% for pancreatic cancer; the specificity for resectable tumors also approached 78%, reported Dr. Masaru Yoshida and his colleagues (Cancer Epidemiol. Biomarkers Prev. 2013 March 29 [doi: 10.1158/1055-9965.EPI-12-1033]).

The panel was more accurate than were any of the currently used biomarkers, including CA19-9 and CEA, said Dr. Yoshida, professor and chief of metabolomics research at Kobe University, Japan, and his colleagues.

"This novel diagnostic approach, which is safe and easy to apply as a screening method, is expected to improve the prognosis of patients with pancreatic cancer by detecting their cancers early, when still in a resectable and curable state," Dr. Yoshida said in a press statement.

The researchers created the panel based on a study of a cohort of 85 subjects: 43 with pancreatic cancer and 42 healthy controls. First, they pared down 113 potentially useful metabolites into a workable testing panel. Of the 45 candidate metabolites, four of them – xylitol, 1,5-anhydro-D-glucitol, histidine, and inositol – showed the highest variation between the healthy controls and the patients. In the training cohort, the panel of these four markers had a sensitivity of 86% and specificity of 88% for pancreatic cancer.

Next, the researchers evaluated a validation cohort of 42 cancer patients, 41 healthy controls, and 23 patients with chronic pancreatitis. In this cohort, with an area under the curve of 0.76, the panel’s sensitivity for pancreatic cancer was 71% and specificity, 78%. In contrast, the sensitivity of CA19-9 was 69% and specificity 86%; for CEA, those numbers were 36% and 80%, respectively.

In the subset of patients with resectable pancreatic cancer, the panel’s sensitivity was 78%, compared with 56% for CA19-9 and 44% for CEA.

The metabolic panel was also able to identify chronic pancreatitis, with a 17% rate of false positives, compared with a false-positive rate of 30% for CA19-9 and 44% for CEA.

A blood panel could address three key problems in the field of pancreatic cancer, Dr. Yoshida and his colleagues said. "The first is the difficulty of detecting pancreatic cancer early in resectable stages. A sensitivity and specificity of about 80% for resectable disease ... should be acceptable for clinical use, because most patients with resectable cancer have no symptoms, and blood examinations are useful tools for initial screening examinations."

The second problem is the difficulty in differentiating pancreatic cancer from chronic pancreatitis. "Many gastroenterologists follow up chronic pancreatitis with scheduled CT, magnetic resonance imaging (MRI), and endoscopic ultrasound scans (EUS); tumor marker tests; and endoscopic retrograde cholangiopancreatography (ERCP), but the initial malignant changes are frequently overlooked, and pancreatic tumors can rapidly become unresectable. In addition, unnecessary resections for benign inflammatory lesions are sometimes done because of false-positive results from CA19-9 and/or imaging examinations."

The third clinical problem is the risk of complications that result from pancreatic examinations. Serum samples are easy and safe to obtain, with a low risk of adverse events and, with this panel, a potentially good return of information. A blood test could also be a useful population screening tool, the researchers noted.

The metabolites probably reflect metabolic derangement that arises not only from focal tumorigenesis, but also from systemic reactions to pancreatic disease, Dr. Yoshida and his coinvestigators wrote. Pancreatic cancer causes significant decreases in some amino and fatty acids, probably because the tumor recruits these substances to aid its rapid cellular proliferation.

"Patients with pancreatic disease are also troubled by malnutrition because of pancreatic endocrine and exocrine insufficiency. Therefore, there is a possibility that the decreases in serum metabolite levels also reflect malnutrition."

Finally, they said, the decrease in 1,5-anhydro-D-glucitol indicates the presence of hyperglycemia and recent glycosuria. "These results suggest that glucose tolerance was impaired in these patients because of pancreatic insufficiency."

The authors reported no financial conflicts. The work was supported by grants administered by agencies of the Japanese government.

msullivan@frontlinemedcom.com

An investigational serum biomarker panel accurately identified potentially resectable cases of pancreatic cancer, opening up the possibility that a blood test could identify the cancer early and improve its dismal prognosis.

The panel measured four metabolites and had an overall sensitivity of 71% and a specificity of 78% for pancreatic cancer; the specificity for resectable tumors also approached 78%, reported Dr. Masaru Yoshida and his colleagues (Cancer Epidemiol. Biomarkers Prev. 2013 March 29 [doi: 10.1158/1055-9965.EPI-12-1033]).

The panel was more accurate than were any of the currently used biomarkers, including CA19-9 and CEA, said Dr. Yoshida, professor and chief of metabolomics research at Kobe University, Japan, and his colleagues.

"This novel diagnostic approach, which is safe and easy to apply as a screening method, is expected to improve the prognosis of patients with pancreatic cancer by detecting their cancers early, when still in a resectable and curable state," Dr. Yoshida said in a press statement.

The researchers created the panel based on a study of a cohort of 85 subjects: 43 with pancreatic cancer and 42 healthy controls. First, they pared down 113 potentially useful metabolites into a workable testing panel. Of the 45 candidate metabolites, four of them – xylitol, 1,5-anhydro-D-glucitol, histidine, and inositol – showed the highest variation between the healthy controls and the patients. In the training cohort, the panel of these four markers had a sensitivity of 86% and specificity of 88% for pancreatic cancer.

Next, the researchers evaluated a validation cohort of 42 cancer patients, 41 healthy controls, and 23 patients with chronic pancreatitis. In this cohort, with an area under the curve of 0.76, the panel’s sensitivity for pancreatic cancer was 71% and specificity, 78%. In contrast, the sensitivity of CA19-9 was 69% and specificity 86%; for CEA, those numbers were 36% and 80%, respectively.

In the subset of patients with resectable pancreatic cancer, the panel’s sensitivity was 78%, compared with 56% for CA19-9 and 44% for CEA.

The metabolic panel was also able to identify chronic pancreatitis, with a 17% rate of false positives, compared with a false-positive rate of 30% for CA19-9 and 44% for CEA.

A blood panel could address three key problems in the field of pancreatic cancer, Dr. Yoshida and his colleagues said. "The first is the difficulty of detecting pancreatic cancer early in resectable stages. A sensitivity and specificity of about 80% for resectable disease ... should be acceptable for clinical use, because most patients with resectable cancer have no symptoms, and blood examinations are useful tools for initial screening examinations."

The second problem is the difficulty in differentiating pancreatic cancer from chronic pancreatitis. "Many gastroenterologists follow up chronic pancreatitis with scheduled CT, magnetic resonance imaging (MRI), and endoscopic ultrasound scans (EUS); tumor marker tests; and endoscopic retrograde cholangiopancreatography (ERCP), but the initial malignant changes are frequently overlooked, and pancreatic tumors can rapidly become unresectable. In addition, unnecessary resections for benign inflammatory lesions are sometimes done because of false-positive results from CA19-9 and/or imaging examinations."

The third clinical problem is the risk of complications that result from pancreatic examinations. Serum samples are easy and safe to obtain, with a low risk of adverse events and, with this panel, a potentially good return of information. A blood test could also be a useful population screening tool, the researchers noted.

The metabolites probably reflect metabolic derangement that arises not only from focal tumorigenesis, but also from systemic reactions to pancreatic disease, Dr. Yoshida and his coinvestigators wrote. Pancreatic cancer causes significant decreases in some amino and fatty acids, probably because the tumor recruits these substances to aid its rapid cellular proliferation.

"Patients with pancreatic disease are also troubled by malnutrition because of pancreatic endocrine and exocrine insufficiency. Therefore, there is a possibility that the decreases in serum metabolite levels also reflect malnutrition."

Finally, they said, the decrease in 1,5-anhydro-D-glucitol indicates the presence of hyperglycemia and recent glycosuria. "These results suggest that glucose tolerance was impaired in these patients because of pancreatic insufficiency."

The authors reported no financial conflicts. The work was supported by grants administered by agencies of the Japanese government.

msullivan@frontlinemedcom.com

An investigational serum biomarker panel accurately identified potentially resectable cases of pancreatic cancer, opening up the possibility that a blood test could identify the cancer early and improve its dismal prognosis.

The panel measured four metabolites and had an overall sensitivity of 71% and a specificity of 78% for pancreatic cancer; the specificity for resectable tumors also approached 78%, reported Dr. Masaru Yoshida and his colleagues (Cancer Epidemiol. Biomarkers Prev. 2013 March 29 [doi: 10.1158/1055-9965.EPI-12-1033]).

The panel was more accurate than were any of the currently used biomarkers, including CA19-9 and CEA, said Dr. Yoshida, professor and chief of metabolomics research at Kobe University, Japan, and his colleagues.

"This novel diagnostic approach, which is safe and easy to apply as a screening method, is expected to improve the prognosis of patients with pancreatic cancer by detecting their cancers early, when still in a resectable and curable state," Dr. Yoshida said in a press statement.

The researchers created the panel based on a study of a cohort of 85 subjects: 43 with pancreatic cancer and 42 healthy controls. First, they pared down 113 potentially useful metabolites into a workable testing panel. Of the 45 candidate metabolites, four of them – xylitol, 1,5-anhydro-D-glucitol, histidine, and inositol – showed the highest variation between the healthy controls and the patients. In the training cohort, the panel of these four markers had a sensitivity of 86% and specificity of 88% for pancreatic cancer.

Next, the researchers evaluated a validation cohort of 42 cancer patients, 41 healthy controls, and 23 patients with chronic pancreatitis. In this cohort, with an area under the curve of 0.76, the panel’s sensitivity for pancreatic cancer was 71% and specificity, 78%. In contrast, the sensitivity of CA19-9 was 69% and specificity 86%; for CEA, those numbers were 36% and 80%, respectively.

In the subset of patients with resectable pancreatic cancer, the panel’s sensitivity was 78%, compared with 56% for CA19-9 and 44% for CEA.

The metabolic panel was also able to identify chronic pancreatitis, with a 17% rate of false positives, compared with a false-positive rate of 30% for CA19-9 and 44% for CEA.

A blood panel could address three key problems in the field of pancreatic cancer, Dr. Yoshida and his colleagues said. "The first is the difficulty of detecting pancreatic cancer early in resectable stages. A sensitivity and specificity of about 80% for resectable disease ... should be acceptable for clinical use, because most patients with resectable cancer have no symptoms, and blood examinations are useful tools for initial screening examinations."

The second problem is the difficulty in differentiating pancreatic cancer from chronic pancreatitis. "Many gastroenterologists follow up chronic pancreatitis with scheduled CT, magnetic resonance imaging (MRI), and endoscopic ultrasound scans (EUS); tumor marker tests; and endoscopic retrograde cholangiopancreatography (ERCP), but the initial malignant changes are frequently overlooked, and pancreatic tumors can rapidly become unresectable. In addition, unnecessary resections for benign inflammatory lesions are sometimes done because of false-positive results from CA19-9 and/or imaging examinations."

The third clinical problem is the risk of complications that result from pancreatic examinations. Serum samples are easy and safe to obtain, with a low risk of adverse events and, with this panel, a potentially good return of information. A blood test could also be a useful population screening tool, the researchers noted.

The metabolites probably reflect metabolic derangement that arises not only from focal tumorigenesis, but also from systemic reactions to pancreatic disease, Dr. Yoshida and his coinvestigators wrote. Pancreatic cancer causes significant decreases in some amino and fatty acids, probably because the tumor recruits these substances to aid its rapid cellular proliferation.

"Patients with pancreatic disease are also troubled by malnutrition because of pancreatic endocrine and exocrine insufficiency. Therefore, there is a possibility that the decreases in serum metabolite levels also reflect malnutrition."

Finally, they said, the decrease in 1,5-anhydro-D-glucitol indicates the presence of hyperglycemia and recent glycosuria. "These results suggest that glucose tolerance was impaired in these patients because of pancreatic insufficiency."

The authors reported no financial conflicts. The work was supported by grants administered by agencies of the Japanese government.

msullivan@frontlinemedcom.com

INDIANAPOLIS – Acute cholecystitis patients fared significantly better with early rather than delayed laparoscopic cholecystectomy in the largest-ever randomized trial addressing surgical timing for this common condition.

Patients assigned to early cholecystectomy – that is, surgery within 24 hours of presentation to the hospital – had one-third the morbidity, markedly shorter hospital lengths of stay, and correspondingly lower hospital costs compared with patients who underwent surgery on day 7-45, according to Dr. Markus W. Buchler of Heidelberg (Ger.) University.

"Early cholecystectomy in patients fit for surgery and in hospitals experienced in doing difficult laparoscopic cholecystectomies should become the standard of care in acute cholecystitis," he declared in presenting the results of the ACDC (Acute Cholecystitis: Early Versus Delayed Cholecystectomy) trial at the annual meeting of the American Surgical Association.

The optimal timing of surgical intervention in acute cholecystitis is a subject of long-standing controversy. The ACDC trial was conducted because in a Cochrane review of five smaller randomized trials totaling 451 acute cholecystitis patients, researchers concluded there was insufficient evidence to say which surgical strategy was best (Cochrane Database Syst. Rev. 2006 Oct 18;4:CD005440).

Dr. Buchler noted that surveys indicate many American surgeons prefer to delay laparoscopic cholecystectomy, while in Germany the surgical preference is for immediate surgery in patients with uncomplicated acute cholecystitis.

The ACDC trial involved 618 patients with uncomplicated acute cholecystitis who were placed on the same antibiotic – moxifloxacin – and randomized to early laparoscopic cholecystectomy or to delayed surgery on day 7-45. Pregnant patients were excluded from the trial, which was conducted at 35 European hospitals, including seven German university medical centers. All participating hospitals were staffed by surgical teams experienced in performing difficult laparoscopic cholecystectomies.

The primary endpoint was total morbidity within 75 days. This included cholangitis, pancreatitis, biliary leak, stroke, myocardial infarction, abscess, bleeding, peritonitis, infection, and renal failure. The rate was 11.6% in the early cholecystectomy group compared with 31.3% with delayed surgery. Among less challenging patients with an ASA score of 2 or less, the rates were 9.7% and 28.6%, respectively. Patients with an ASA score above 2 had an overall morbidity rate of 20% with early surgery compared with 47% with delayed laparoscopic cholecystectomy.

The rate of conversion to open surgery was 9.9% in the early laparoscopic cholecystectomy group and similar at 11.9% in the delayed surgery group. This came as a surprise to Dr. Buchler and his coinvestigators. They expected a significantly higher conversion rate in conjunction with delayed laparoscopic cholecystectomy.

"I think what this tells us is surgeons have gotten really good at laparoscopic cholecystectomy even in more difficult situations," he observed.

Total hospital stays averaged 5.4 days in the early surgery group compared with 10.0 days with delayed surgery. Mean total hospital costs calculated via the German DRG system were 2,919 euro in the early cholecystectomy group and 4,261 euro with delayed surgery.

Discussant Dr. Andrew L. Warshaw praised Dr. Buchler and his coworkers in the German surgical clinical trials study group for their "leadership in determining evidence-based standards of care."

"There’s no doubt in my mind that immediate cholecystectomy is superior in this patient population," said Dr. Warshaw, professor and chairman of the department of surgery at Harvard Medical School, Boston.

Noting that most acute cholecystitis patients are first seen by an internist or gastroenterologist who then makes the initial treatment decision, Dr. Warshaw asked Dr. Buchler if German internists and gastroenterologists have gotten on board this immediate surgery treatment pathway.

"Convincing internists and gastroenterologists will take a long time, at least in Germany," the surgeon replied. "It is much easier to convince the emergency department physicians to refer patients early to surgery; they’re much closer to the surgeons."

He noted that German surgical practice differs from that in the United States in several respects. For one, German patients routinely stay in the hospital longer, even if they don’t experience complications. That’s why the mean length of stay after cholecystectomy in ACDC was 4.68 days in the early surgery group and closely similar at 4.89 days in the delayed surgery group, even though the delayed surgery group had a threefold higher complication rate.

Another difference is that, unlike in this country, intraoperative cholangiography is rarely done in Germany.

"It’s the absolute exception that intraoperative cholangiography is used. It is used only when there’s a reason for it, such as jaundice. There was probably less than a 3% intraoperative cholangiography rate in this trial," said Dr. Buchler.

The ACDC trial was funded with government research grants. Dr. Buchler reported having no financial conflicts.

bjancin@frontlinemedcom.com

INDIANAPOLIS – Acute cholecystitis patients fared significantly better with early rather than delayed laparoscopic cholecystectomy in the largest-ever randomized trial addressing surgical timing for this common condition.

Patients assigned to early cholecystectomy – that is, surgery within 24 hours of presentation to the hospital – had one-third the morbidity, markedly shorter hospital lengths of stay, and correspondingly lower hospital costs compared with patients who underwent surgery on day 7-45, according to Dr. Markus W. Buchler of Heidelberg (Ger.) University.

"Early cholecystectomy in patients fit for surgery and in hospitals experienced in doing difficult laparoscopic cholecystectomies should become the standard of care in acute cholecystitis," he declared in presenting the results of the ACDC (Acute Cholecystitis: Early Versus Delayed Cholecystectomy) trial at the annual meeting of the American Surgical Association.

The optimal timing of surgical intervention in acute cholecystitis is a subject of long-standing controversy. The ACDC trial was conducted because in a Cochrane review of five smaller randomized trials totaling 451 acute cholecystitis patients, researchers concluded there was insufficient evidence to say which surgical strategy was best (Cochrane Database Syst. Rev. 2006 Oct 18;4:CD005440).

Dr. Buchler noted that surveys indicate many American surgeons prefer to delay laparoscopic cholecystectomy, while in Germany the surgical preference is for immediate surgery in patients with uncomplicated acute cholecystitis.

The ACDC trial involved 618 patients with uncomplicated acute cholecystitis who were placed on the same antibiotic – moxifloxacin – and randomized to early laparoscopic cholecystectomy or to delayed surgery on day 7-45. Pregnant patients were excluded from the trial, which was conducted at 35 European hospitals, including seven German university medical centers. All participating hospitals were staffed by surgical teams experienced in performing difficult laparoscopic cholecystectomies.

The primary endpoint was total morbidity within 75 days. This included cholangitis, pancreatitis, biliary leak, stroke, myocardial infarction, abscess, bleeding, peritonitis, infection, and renal failure. The rate was 11.6% in the early cholecystectomy group compared with 31.3% with delayed surgery. Among less challenging patients with an ASA score of 2 or less, the rates were 9.7% and 28.6%, respectively. Patients with an ASA score above 2 had an overall morbidity rate of 20% with early surgery compared with 47% with delayed laparoscopic cholecystectomy.

The rate of conversion to open surgery was 9.9% in the early laparoscopic cholecystectomy group and similar at 11.9% in the delayed surgery group. This came as a surprise to Dr. Buchler and his coinvestigators. They expected a significantly higher conversion rate in conjunction with delayed laparoscopic cholecystectomy.

"I think what this tells us is surgeons have gotten really good at laparoscopic cholecystectomy even in more difficult situations," he observed.

Total hospital stays averaged 5.4 days in the early surgery group compared with 10.0 days with delayed surgery. Mean total hospital costs calculated via the German DRG system were 2,919 euro in the early cholecystectomy group and 4,261 euro with delayed surgery.

Discussant Dr. Andrew L. Warshaw praised Dr. Buchler and his coworkers in the German surgical clinical trials study group for their "leadership in determining evidence-based standards of care."

"There’s no doubt in my mind that immediate cholecystectomy is superior in this patient population," said Dr. Warshaw, professor and chairman of the department of surgery at Harvard Medical School, Boston.

Noting that most acute cholecystitis patients are first seen by an internist or gastroenterologist who then makes the initial treatment decision, Dr. Warshaw asked Dr. Buchler if German internists and gastroenterologists have gotten on board this immediate surgery treatment pathway.

"Convincing internists and gastroenterologists will take a long time, at least in Germany," the surgeon replied. "It is much easier to convince the emergency department physicians to refer patients early to surgery; they’re much closer to the surgeons."

He noted that German surgical practice differs from that in the United States in several respects. For one, German patients routinely stay in the hospital longer, even if they don’t experience complications. That’s why the mean length of stay after cholecystectomy in ACDC was 4.68 days in the early surgery group and closely similar at 4.89 days in the delayed surgery group, even though the delayed surgery group had a threefold higher complication rate.

Another difference is that, unlike in this country, intraoperative cholangiography is rarely done in Germany.

"It’s the absolute exception that intraoperative cholangiography is used. It is used only when there’s a reason for it, such as jaundice. There was probably less than a 3% intraoperative cholangiography rate in this trial," said Dr. Buchler.

The ACDC trial was funded with government research grants. Dr. Buchler reported having no financial conflicts.

bjancin@frontlinemedcom.com

INDIANAPOLIS – Acute cholecystitis patients fared significantly better with early rather than delayed laparoscopic cholecystectomy in the largest-ever randomized trial addressing surgical timing for this common condition.

Patients assigned to early cholecystectomy – that is, surgery within 24 hours of presentation to the hospital – had one-third the morbidity, markedly shorter hospital lengths of stay, and correspondingly lower hospital costs compared with patients who underwent surgery on day 7-45, according to Dr. Markus W. Buchler of Heidelberg (Ger.) University.

"Early cholecystectomy in patients fit for surgery and in hospitals experienced in doing difficult laparoscopic cholecystectomies should become the standard of care in acute cholecystitis," he declared in presenting the results of the ACDC (Acute Cholecystitis: Early Versus Delayed Cholecystectomy) trial at the annual meeting of the American Surgical Association.

The optimal timing of surgical intervention in acute cholecystitis is a subject of long-standing controversy. The ACDC trial was conducted because in a Cochrane review of five smaller randomized trials totaling 451 acute cholecystitis patients, researchers concluded there was insufficient evidence to say which surgical strategy was best (Cochrane Database Syst. Rev. 2006 Oct 18;4:CD005440).

Dr. Buchler noted that surveys indicate many American surgeons prefer to delay laparoscopic cholecystectomy, while in Germany the surgical preference is for immediate surgery in patients with uncomplicated acute cholecystitis.

The ACDC trial involved 618 patients with uncomplicated acute cholecystitis who were placed on the same antibiotic – moxifloxacin – and randomized to early laparoscopic cholecystectomy or to delayed surgery on day 7-45. Pregnant patients were excluded from the trial, which was conducted at 35 European hospitals, including seven German university medical centers. All participating hospitals were staffed by surgical teams experienced in performing difficult laparoscopic cholecystectomies.

The primary endpoint was total morbidity within 75 days. This included cholangitis, pancreatitis, biliary leak, stroke, myocardial infarction, abscess, bleeding, peritonitis, infection, and renal failure. The rate was 11.6% in the early cholecystectomy group compared with 31.3% with delayed surgery. Among less challenging patients with an ASA score of 2 or less, the rates were 9.7% and 28.6%, respectively. Patients with an ASA score above 2 had an overall morbidity rate of 20% with early surgery compared with 47% with delayed laparoscopic cholecystectomy.

The rate of conversion to open surgery was 9.9% in the early laparoscopic cholecystectomy group and similar at 11.9% in the delayed surgery group. This came as a surprise to Dr. Buchler and his coinvestigators. They expected a significantly higher conversion rate in conjunction with delayed laparoscopic cholecystectomy.

"I think what this tells us is surgeons have gotten really good at laparoscopic cholecystectomy even in more difficult situations," he observed.

Total hospital stays averaged 5.4 days in the early surgery group compared with 10.0 days with delayed surgery. Mean total hospital costs calculated via the German DRG system were 2,919 euro in the early cholecystectomy group and 4,261 euro with delayed surgery.

Discussant Dr. Andrew L. Warshaw praised Dr. Buchler and his coworkers in the German surgical clinical trials study group for their "leadership in determining evidence-based standards of care."

"There’s no doubt in my mind that immediate cholecystectomy is superior in this patient population," said Dr. Warshaw, professor and chairman of the department of surgery at Harvard Medical School, Boston.

Noting that most acute cholecystitis patients are first seen by an internist or gastroenterologist who then makes the initial treatment decision, Dr. Warshaw asked Dr. Buchler if German internists and gastroenterologists have gotten on board this immediate surgery treatment pathway.

"Convincing internists and gastroenterologists will take a long time, at least in Germany," the surgeon replied. "It is much easier to convince the emergency department physicians to refer patients early to surgery; they’re much closer to the surgeons."

He noted that German surgical practice differs from that in the United States in several respects. For one, German patients routinely stay in the hospital longer, even if they don’t experience complications. That’s why the mean length of stay after cholecystectomy in ACDC was 4.68 days in the early surgery group and closely similar at 4.89 days in the delayed surgery group, even though the delayed surgery group had a threefold higher complication rate.

Another difference is that, unlike in this country, intraoperative cholangiography is rarely done in Germany.

"It’s the absolute exception that intraoperative cholangiography is used. It is used only when there’s a reason for it, such as jaundice. There was probably less than a 3% intraoperative cholangiography rate in this trial," said Dr. Buchler.

The ACDC trial was funded with government research grants. Dr. Buchler reported having no financial conflicts.

bjancin@frontlinemedcom.com