GI and Hepatology News

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Last month, I had the privilege of joining more than one hundred physician colleagues in Washington, DC, for AGA Advocacy Day. While standing amidst the majesty of the Capital, I found myself deeply appreciative for those who dedicate their time and energy to public service. Many of these dedicated federal workers choose to be in DC because of a sincere belief in their mission.

Among these mission-driven public servants are federal employees who work in the Department of Veterans Affairs (VA). As a member of this group, I come to work energized by the mission to care for those who have served in our military. In my clinical practice, I am reminded regularly of the sacrifices of veterans and their families. This month, and especially on Veterans Day, I hope we will take a moment to express gratitude to veterans for their service to our country.

This month is also a timely opportunity to recognize the immense contributions of VA physicians to the field of gastroenterology. Many young gastroenterologists may not know that it was the landmark VA Cooperative Study #380, led by Dr. David Lieberman (Portland VA) that helped push Medicare to cover reimbursement for screening colonoscopy. Today, one of the most important ongoing studies in our field – VA Cooperative Study #577 – continues the VA tradition of high-impact health services research. Launched in 2012, the study has enrolled 50,000 veterans to compare FIT and colonoscopy. It is led by Dr. Jason Dominitz (Seattle VA) and Dr. Doug Robertson (White River Junction VA). 

Beyond research, VA gastroenterologists play a critical role in training the next generation of clinicians. Over 700 gastroenterologists count the VA as a clinical home, making it the largest GI group practice in the country. Many of us — myself included — were trained or mentored by VA physicians whose dedication to service and science has shaped our careers and the field at large.

This month’s issue of GI & Hepatology News has stories about other important contributions to our field. The stories and perspective pieces on Artificial Intelligence are particularly poignant given the announcement last month on the awarding of the Nobel Prize in economics to researchers who study “creative destruction,” the way in which one technological innovation renders others obsolete. Perhaps this award offers another reason to reemphasize and embrace the “art” of medicine.

The views expressed here are my own and do not necessarily reflect the official policy or position of the U.S. Department of Veterans Affairs or the United States Government.

Ziad Gellad, MD, MPH, AGAF

Associate Editor

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

Dear colleagues,

Since our last Perspectives feature on artificial intelligence (AI) in gastroenterology and hepatology, the field has experienced remarkable growth in both innovation and clinical adoption. AI tools that were once conceptual are now entering everyday practice, with many more on the horizon poised to transform how we diagnose, treat, and manage patients. In this issue of Perspectives, we present two timely essays that explore how AI is reshaping clinical care—while also emphasizing the need for caution, thoughtful integration, and ongoing oversight.

Dr. Yuvaraj Singh, Dr. Alessandro Colletta, and Dr. Neil Marya discuss how purpose-built AI models can reduce diagnostic uncertainty in advanced endoscopy. From cholangioscopy systems that outperform standard ERCP sampling in distinguishing malignant biliary strictures to EUS-based platforms that differentiate autoimmune pancreatitis from pancreatic cancer, they envision a near-term future in which machine intelligence enhances accuracy, accelerates decision-making, and refines interpretation—without replacing the clinician’s expertise.

Complementing this, Dr. Dennis Shung takes a broader view across the endoscopy unit and outpatient clinic. He highlights the promise of AI for polyp detection, digital biopsy, and automated reporting, while underscoring the importance of human oversight, workflow integration, and safeguards against misinformation. Dr. Shung also emphasizes the pivotal role professional societies can play in establishing clear standards, ethical boundaries, and trusted frameworks for AI deployment in GI practice.

We hope these perspectives spark practical conversations about when—and how—to integrate AI in your own practice. As always, we welcome your feedback and real-world experience. Join the conversation on X at @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, and chief of endoscopy at West Haven VA Medical Center, both in Connecticut. He is an associate editor for GI & Hepatology News.

AI Models in Advanced Endoscopy

BY YUVARAJ SINGH, MD; ALESSANDRO COLLETTA, MD; NEIL MARYA, MD

As the adage goes, “if tumor is the rumor, then tissue is the issue, because cancer may be the answer.”

Establishing an accurate diagnosis is the essential first step toward curing or palliating malignancy. From detecting an early neoplastic lesion, to distinguishing between malignant and benign pathology, or to determining when and where to obtain tissue, endoscopists are frequently faced with the challenge of transforming diagnostic suspicion into certainty.

Artificial intelligence (AI), designed to replicate human cognition such as pattern recognition and decision-making, has emerged as a technology to assist gastroenterologists in addressing a variety of different tasks during endoscopy. AI research in gastrointestinal endoscopy has initially focused on computer-aided detection (CADe) of colorectal polyps. More recently, however, there has been increased emphasis on developing AI to assist advanced endoscopists.

For instance, in biliary endoscopy, AI is being explored to improve the notoriously challenging diagnosis of cholangiocarcinoma, where conventional tissue sampling often falls short of providing a definitive diagnosis. Similarly, in the pancreas, AI models are showing potential to differentiate autoimmune pancreatitis (AIP) from pancreatic ductal adenocarcinoma (PDAC), a distinction with profound therapeutic implications. Even pancreatic cysts are beginning to benefit from AI models that refine risk stratification and guide management. Together, these advances underscore how AI is not merely an adjunct but a potentially massive catalyst for reimagining the diagnostic role of advanced endoscopists.

Classifying biliary strictures (MBS) accurately remains a challenge. Standard ERCP-based sampling techniques (forceps biopsy and brush cytology) are suboptimal diagnostic tools with false negative rates for detecting MBS of less than 50%. The diagnostic uncertainty related to biliary stricture classification carries significant consequences for patients. For example, patients with biliary cancer without positive cytology have treatments delayed until a malignant diagnosis is established. 

Ancillary technologies to enhance ERCP-based tissue acquisition are still weighed down by low sensitivity and accuracy; even with ancillary use of fluorescent in situ hybridization (FISH), diagnostic yield remains limited. EUS-FNA can help with distal biliary strictures, but this technique risks needle-tract seeding in cases of perihilar disease. Cholangioscopy allows for direct visualization and targeted sampling; however, cholangioscopy-guided forceps biopsies are burdened by low sensitivities.¹ Additionally, physician interpretation of visual findings during cholangioscopy often suffers from poor interobserver agreement and poor accuracy.²

To improve the classification of biliary strictures, several groups have studied the application of AI for cholangioscopy footage of biliary pathology. In our lab, we trained an AI incorporating over 2.3 million cholangioscopy still images and nearly 20,000 expert-annotated frames to enhance its development. The AI closely mirrored expert labeling of cholangioscopy images of malignant pathology and, when tested on full cholangioscopy videos of indeterminate biliary strictures, the AI achieved a diagnostic accuracy of 91%—outperforming both brush cytology (63%) and forceps biopsy (61%).³

The results from this initial study were later validated across multiple centers. AI-assisted cholangioscopy could thus offer a reproducible, real-world solution to one of the most persistent diagnostic dilemmas advanced endoscopists face—helping clinicians act earlier and with greater confidence when evaluating indeterminate strictures.

Moving from the biliary tree to the pancreas, autoimmune pancreatitis (AIP) is a benign fibro-inflammatory disease that often frustrates advanced endoscopists as it closely mimics the appearance of pancreatic ductal adenocarcinoma (PDAC). The stakes are high: despite modern diagnostic techniques, including advanced imaging, some patients with pancreatic resections for “suspected PDAC” are still found to have AIP on final pathology. Conventional tools to distinguish AIP from PDAC have gaps: serum IgG4 and EUS-guided biopsies are both specific but insensitive.

Using EUS videos and images of various pancreas pathologies at Mayo Clinic, we developed an AI to tackle this dilemma. After intensive training, the EUS AI achieved a greater accuracy for distinguishing AIP from PDAC than a group of expert Mayo clinic endosonographers.⁵ In practice, an EUS-AI can identify AIP patterns in real-time, guiding clinicians toward steroid trials or biopsies and reducing the need for unnecessary surgeries.

Looking ahead, there are multiple opportunities for integration of AI into advanced endoscopy practices. Ongoing research suggests that AI could soon assist with identification of pancreas cysts most at risk for malignant transformation, classification of high risk Barrett’s esophagus, and even help with rapid on-site assessment of cytologic specimens obtained during EUS. Beyond diagnosis, AI could likely play an important role in guiding therapeutic interventions. For example, an ERCP AI in the future may be able to provide cannulation assistance or an AI assistant could help endosonographers during deployments of lumen apposing metal stents.

By enhancing image interpretation and procedural consistency, AI has the potential to uphold the fundamental principle of primum non nocere, enabling us to intervene with precision while minimizing harm. AI can also bridge grey zones in clinical practice and narrow diagnostic uncertainty in real time. Importantly, these systems can help clinicians achieve expertise in a fraction of the time it traditionally takes to acquire comparable human proficiency, while offering wider availability across practice settings and reducing interobserver variability that has long challenged endoscopic interpretation.

Currently, adoption is limited by high bias risk, lack of external validation, and interpretability Still, the trajectory of AI suggests a future where these computer technologies will not only support but also elevate human expertise, reshaping the standards of care of diseases managed by advanced endoscopists.

Dr. Singh, Dr. Colletta, and Dr. Marya are based at the Division of Gastroenterology and Hepatology, UMass Chan Medical School, Worcester, Massachusetts. Dr. Marya is a consultant for Boston Scientific, and has no other disclosures. Dr. Singh and Dr. Colletta have no disclosures.

References

1. Navaneethan U, et al. Comparative effectiveness of biliary brush cytology and intraductal biopsy for detection of malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2015 Jan. doi: 10.1016/j.gie.2014.09.017.

2. Stassen PMC, et al. Diagnostic accuracy and interobserver agreement of digital single-operator cholangioscopy for indeterminate biliary strictures. Gastrointest Endosc 2021 Dec. doi: 10.1016/j.gie.2021.06.027.

3. Marya NB, et al. Identification of patients with malignant biliary strictures using a cholangioscopy-based deep learning artificial intelligence (with video). Gastrointest Endosc. 2023 Feb. doi: 10.1016/j.gie.2022.08.021.

4. Marya NB, et al. Multicenter validation of a cholangioscopy artificial intelligence system for the evaluation of biliary tract disease. Endoscopy. 2025 Aug. doi: 10.1055/a-2650-0789.

5. Marya NB, et al. Utilisation of artificial intelligence for the development of an EUS-convolutional neural network model trained to enhance the diagnosis of autoimmune pancreatitis. Gut. 2021 Jul. doi: 10.1136/gutjnl-2020-322821.

AI in General GI and Endoscopy

BY DENNIS L. SHUNG, MD, MHS, PHD

The practice of gastroenterology is changing, but much of it will be rooted in the same – careful, focused attention on endoscopic procedures, and compassionate, attentive care in clinic. Artificial intelligence (AI), like the Industrial Revolution before, is going to transform our practice. This comes with upsides and downsides, and highlights the need for strong leadership from our societies to safeguard the technology for practitioners and patients.

What are the upsides? 

AI has the potential to serve as a second set of eyes in detecting colon polyps, increasing the adenoma detection rate (ADR).¹ AI can be applied to all areas of the gastrointestinal tract, providing digital biopsies, guiding resection, and ensuring quality, which are all now possible with powerful new endoscopy foundation models, such as GastroNet-5M.²

Additionally. the advent of automating the collection of data into reports may herald the end of our days as data entry clerks. Generative AI also has the potential to give us all the best information at our fingertips, suggesting guideline-based care, providing the most up to date evidence, and guiding the differential diagnosis. The potential for patient-facing AI systems could lead to better health literacy, more meaningful engagement, and improved patient satisfaction.³

What are the downsides? 

For endoscopy, AI cannot make up for poor technique to ensure adequate mucosal exposure by the endoscopist, and an increase in AI-supported ADR does not yet convincingly translate into concrete gains in colorectal cancer-related mortality. For the foreseeable future, AI cannot make a connection with the patient in front of us, which is critical in diagnosing and treating patients.

Currently, AI appears to worsen loneliness⁴, and does not necessarily deepen the bonds or provide the positive touch that can heal, and which for many of us, was the reason we became physicians. Finally, as information proliferates, the information risk to patients and providers is growing – in the future, trusted sources to monitor, curate, and guide AI will be ever more important.

 

Black Swans

As AI begins to mature, there are risks that lurk beneath the surface. When regulatory bodies begin to look at AI-assisted diagnostics or therapeutics as the new standard of care, reimbursement models may adjust, and providers may be left behind. The rapid proliferation and haphazard adoption of AI could lead to overdependence and deskilling or result in weird and as yet unknown errors that are difficult to troubleshoot.

What is the role of the GI societies? 

Specialty societies like AGA are taking leadership roles in determining the bounds of where AIs may tread, not just in providing information to their membership but also in digesting evidence and synthesizing recommendations. Societies must balance the real promise of AI in endoscopy with the practice realities for members, and provide living guidelines that reflect the consensus of members regarding scope of practice with the ability to update as new data become available.⁵

Societies also have a role as advocates for safety, taking ownership of high-quality content to prevent misinformation. AGA recently announced the development of a chat interface that will be focused on providing its members the highest quality information, and serve as a portal to identify and respond to its members’ information needs. By staying united rather than fragmenting, societies can maintain bounds to protect its members and their patients and advance areas where there is clinical need, together.

Dr. Shung is senior associate consultant, Division of Gastroenterology and Hepatology, and director of clinical generative artificial intelligence and informatics, Department of Medicine, at Mayo Clinic Rochester, Minnesota. He has no disclosures in regard to this article.

References

1. Soleymanjahi S, et al. Artificial Intelligence-Assisted Colonoscopy for Polyp Detection : A Systematic Review and Meta-analysis. Ann Intern Med. 2024 Dec. doi:10.7326/annals-24-00981.

2. Jong MR, et al. GastroNet-5M: A Multicenter Dataset for Developing Foundation Models in Gastrointestinal Endoscopy. Gastroenterology. 2025 Jul. doi: 10.1053/j.gastro.2025.07.030.

3. Soroush A, et al. Generative Artificial Intelligence in Clinical Medicine and Impact on Gastroenterology. Gastroenterology. 2025 Aug. doi: 10.1053/j.gastro.2025.03.038.

4. Mengying Fang C, et al. How AI and Human Behaviors Shape Psychosocial Effects of Extended Chatbot Use: A Longitudinal Randomized Controlled Study. arXiv e-prints. 2025 Mar. doi: 10.48550/arXiv.2503.17473.

5. Sultan S, et al. AGA Living Clinical Practice Guideline on Computer-Aided Detection-Assisted Colonoscopy. Gastroenterology. 2025 Apr. doi:10.1053/j.gastro.2025.01.002.

BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.

A large UK Biobank study found that higher intakes of both sugar-sweetened beverages (SSBs) and low- and non-SSBs (LNSSBs) were significantly associated with a higher risk of developing metabolic dysfunction-associated steatotic liver disease (MASLD).

In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.

“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.

She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

 

Stick With Water

MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.

To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”

Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.

The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.

In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).

Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.

Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.

Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.

Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.

“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.

“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.

 

More Study Needed

Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”

He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”

“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.

“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.

“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.

Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.

The study had no specific funding. Liu and Janardhan had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.

A large UK Biobank study found that higher intakes of both sugar-sweetened beverages (SSBs) and low- and non-SSBs (LNSSBs) were significantly associated with a higher risk of developing metabolic dysfunction-associated steatotic liver disease (MASLD).

In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.

“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.

She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

 

Stick With Water

MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.

To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”

Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.

The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.

In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).

Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.

Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.

Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.

Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.

“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.

“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.

 

More Study Needed

Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”

He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”

“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.

“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.

“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.

Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.

The study had no specific funding. Liu and Janardhan had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

BERLIN — Diet drinks may not be “healthier” than sugary drinks when it comes to liver health.

A large UK Biobank study found that higher intakes of both sugar-sweetened beverages (SSBs) and low- and non-SSBs (LNSSBs) were significantly associated with a higher risk of developing metabolic dysfunction-associated steatotic liver disease (MASLD).

In fact, low- or artificially sweetened beverages were actually linked to a higher risk for MASLD than sugar-laden drinks, even at modest intake levels such as a single can per day.

“These findings challenge the common perception that these drinks are harmless and highlight the need to reconsider their role in diet and liver health, especially as MASLD emerges as a global health concern,” lead author Lihe Liu, a graduate student in the Department of Gastroenterology at The First Affiliated Hospital of Soochow University in Suzhou, China, said in a news release.

She presented her research at the United European Gastroenterology (UEG) Week 2025 in Berlin, Germany.

 

Stick With Water

MASLD affects 38% of the global population and has become a leading cause of cirrhosis, liver cancer, and liver-related death. Lifestyle modification remains “a cornerstone” of MASLD management. Current guidelines advise against SSBs, but the evidence regarding LNSSBs remains “limited,” Liu explained in her presentation.

To investigate, the researchers analyzed data of 123,788 UK Biobank participants without liver disease at baseline who were followed for an average of 10.3 years. Beverage consumption was assessed through repeated 24-hour dietary questionnaires using the question: “How many glasses, cans, or cartons containing 250 mL (roughly 250 g) of SSBs or LNSSBs did you drink yesterday?”

Intake was averaged across at least two recalls, and participants were grouped into three intake categories: none, more than 0 to one serving per day, or more than one serving per day.

The primary outcome was incident MASLD, and secondary outcomes included liver-related mortality and liver fat content measured using MRI-derived proton density fat fraction.

In the fully adjusted multivariable Cox model, compared with no consumption, consuming more than one serving of LNSSBs daily was associated with a 60% higher risk for MASLD (hazard ratio [HR], 1.599). The level of consumption of SSBs was associated with a 50% higher risk (HR, 1.469).

Consuming more than one serving of LNSSBs daily was also associated with a higher risk for severe liver outcomes (HR, 1.555), while SSBs showed no significant association after adjustment.

Neither SSBs nor LNSSBs showed significant associations with all-cause mortality in fully adjusted models.

Substituting either beverage with water reduced the risk for MASLD by 12.8% for SSBs and 15.2% for LNSSBs, Liu reported.

Both beverage types were positively associated with higher liver fat content. Consumption of more than one serving of SSBs and LNSSBs daily was associated with about 5% and 7% higher liver fat levels, respectively, than nonconsumption.

“The higher sugar content in SSBs can cause rapid spikes in blood glucose and insulin, promote weight gain, and increase uric acid levels, all of which contribute to liver fat accumulation. LNSSBs, on the other hand, may affect liver health by altering the gut microbiome, disrupting the feeling of fullness, driving sweet cravings, and even stimulating insulin secretion,” Liu said.

“The safest approach is to limit both sugar-sweetened and artificially sweetened drinks. Water remains the best choice as it removes the metabolic burden and prevents fat accumulation in the liver, whilst hydrating the body,” she concluded.

 

More Study Needed

Reached for comment, Sujit V. Janardhan, MD, PhD, director of the steatotic liver disease program, Rush University Medical Center, Chicago, said the findings “certainly should cause one to take pause from the popular notion that diet or non-sugar-sweetened beverages are healthier than their sugar-sweetened alternatives.”

He cautioned, however, that it would be “important to confirm confounders are adequately addressed in this large population-based study.”

“We must better understand what other exposure and characteristics were present in patients who had increased intake of non-sugar-sweetened beverages,” Janardhan told GI & Hepatology News.

“For example, it’s possible people who drank more non-sugar-sweetened beverages had more cardiovascular or metabolic risk factors (which prompted them to switch to the ‘diet’ alternative) and that it is these comorbidities that drove an association with increased MASLD incidence and liver-related mortality,” Janardhan noted.

“If there is one finding that seems easy to take away from this study, it’s that people who drank more water in place of sweetened beverages had reduced risk of MASLD,” he told GI & Hepatology News.

Therefore, while awaiting results of mechanistic studies and careful confounder analysis, “plain old boring water is your best bet,” Janardhan said.

The study had no specific funding. Liu and Janardhan had no relevant disclosures.

 

A version of this article appeared on Medscape.com.

BERLIN — Women who use menopausal hormone therapy (MHT; ie, hormone replacement therapy ) have an up to 30% reduction in the risk of developing esophageal and gastric cancers compared to nonusers, according to a large population-based study across five Nordic countries. The association appeared strongest for combined estrogen-progestin and systemic formulations.

“This is one of the largest and most comprehensive studies to date supporting the hypothesis of an inverse association between MHT and risk of esophago-gastric cancer,” said Victoria Wocalewski, MD, from the Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, who presented the findings at United European Gastroenterology (UEG) Week 2025. 

There was a decreased risk for all investigated cancers in MHT users, but the strongest association was observed for esophageal adenocarcinoma (EAC), said Wocalewski. In addition, “there were discrete dose-dependent results for [EAC] and gastric adenocarcinoma (GAC) but not for esophageal squamous cell carcinoma (ESCC).”

 

Large Population-Based Study 

Previous research has suggested that hormonal changes could partly explain the male predominance in esophageal and gastric cancers, but evidence from large, well-controlled datasets has been limited. 

“Cancer rates in women increase significantly after age of 60, so it has been hypothesized that this pattern is linked to declined levels of estrogen that comes with menopause,” said Wocalewski, explaining the rationale for the study.

“Some studies looking at MHT use have indicated a possible protective effect, but with some contradictory results and type-specific variations,” Wocalewski noted. “Our study aimed to investigate these previous findings using a larger study sample.”

The population-based case-control study drew on prospectively collected data from the NordGETS database including national prescription, cancer, and population registries in Denmark, Finland, Iceland, Norway, and Sweden spanning 1994-2020. In total, 19,518 women with esophago-gastric cancer were compared with 195,094 controls randomly selected from the general population, and matched for age, calendar year, and country (in a 1:10 ratio). Women were 45 years or over with a diagnosis of EAC, ESCC, or GAC. 

In total there were 5000 cases of EAC, 4401 of ESCC, and 10,117 of GAC, with the median ages being 74, 72, and 75 years, respectively; most cases of EAC and ESCC were found in Denmark, and most cases of GAC were in Sweden. 

The investigators categorized participants by defined daily doses (DDDs) of MHT into three equal sized categories: low (< 158 DDDs), intermediate (158-848 DDDs), and high (> 848 DDDs). MHT was defined as systemic or local, and estrogen only or combined with progesterone. Odds ratios (ORs) were calculated for three major cancer outcomes of EAC, ESCC, and GAC, adjusted for known confounders such as age, obesity, smoking, alcohol consumption, reflux disease, Helicobacter pylori eradication, and concomitant use of statins or non-steroidal anti-inflammatory drugs (NSAIDs). However, Wocalewski noted that they did not adjust for socio-economic factors. 

 

Significant Reductions Across Esophago-Gastric Cancers

Compared with nonusers, women with any MHT exposure had a markedly reduced risk of EAC with adjusted ORs (aORs) of 0.74 (95% CI, 0.67-0.81) for low-use, 0.68 (95% CI, 0.61-0.75) for intermediate-use, and 0.68 (95% CI, 0.61-0.75) for high-use groups. Various adjustments were made for obesity, reflux, statins, and NSAIDs, as well as smoking, alcohol use, and H pylori eradication.

Similar inverse associations were seen for ESCC with aORs of 0.69 (95% CI, 0.62-0.77), 0.70 (95% CI, 0.62-0.77), and 0.71 (95% CI, 0.64-0.79) across the dose categories, and for GAC where risk decreased progressively from 0.90 (95% CI, 0.84-0.96) to 0.80 (95% CI, 0.74-0.86) across increasing MHT doses.

When stratified by hormone formulation, combined estrogen-progesterone therapy and systemic MHT conferred the strongest risk reduction. For example, systemic MHT use was associated with aORs of 0.67 (95% CI, 0.61-0.74) for EAC and 0.82 (95% CI, 0.76-0.88) for GAC, while local (vaginal) preparations showed slightly weaker associations at 0.72 (95% CI, 0.66-0.78) and 0.87 (95% CI, 0.83-0.92), respectively. 

In EAC, combined estrogen-progesterone therapy led to an OR of 0.68 (95% CI, 0.63-0.73) and 0.77 (95% CI, 0.69-0.87) for women on estrogen alone. Similar results were found for ESCC. For GAC, combination resulted in an aOR of 0.85 (95% CI, 0.80-0.89) and 0.88 (95% CI, 0.81-0.97) in estrogen only therapy respectively.

“Our results reinforce the concept that estrogenic signaling may influence tumor development in the upper GI tract,” said Wocalewski. “Understanding these mechanisms could help identify at-risk populations and inform prevention strategies,” she added, noting that, “hormonal effects on epithelial tight junctions and nitric oxide synthesis in the gastrointestinal tract” would have an influence on smooth muscle cells.

 

Link Between Hormones and GI Pathology

Commenting on the study for GI & Hepatology News, Jan Bornschein, MD, University of Oxford, UK, who was not involved in the research, said the results are “highly relevant.” 

“We’ve seen for a long time a link between hormones and GI pathology, however, it has been poorly investigated and the whole mechanisms are not understood, so it’s welcome that this group is moving forward and investigating this in a structured way,” he said.

Another delegate cautioned that MHT was associated with a risk for other non- gastrointestinal cancers. “I think it’s extremely important, because there are data on associations [of MHT] with breast cancer and also endometrial cancer. It’s good to see that it may help and reduce this cancer, but we have to be really careful about the others.”

Wocalewski reports no relevant conflicts of interest. Bornschein has no disclosures relevant to this study. The study was funded by Karolinska Institutet and supported by national cancer and prescription registry data from Denmark, Finland, Iceland, Norway, and Sweden.

 

A version of this article appeared on Medscape.com.

BERLIN — Women who use menopausal hormone therapy (MHT; ie, hormone replacement therapy ) have an up to 30% reduction in the risk of developing esophageal and gastric cancers compared to nonusers, according to a large population-based study across five Nordic countries. The association appeared strongest for combined estrogen-progestin and systemic formulations.

“This is one of the largest and most comprehensive studies to date supporting the hypothesis of an inverse association between MHT and risk of esophago-gastric cancer,” said Victoria Wocalewski, MD, from the Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, who presented the findings at United European Gastroenterology (UEG) Week 2025. 

There was a decreased risk for all investigated cancers in MHT users, but the strongest association was observed for esophageal adenocarcinoma (EAC), said Wocalewski. In addition, “there were discrete dose-dependent results for [EAC] and gastric adenocarcinoma (GAC) but not for esophageal squamous cell carcinoma (ESCC).”

 

Large Population-Based Study 

Previous research has suggested that hormonal changes could partly explain the male predominance in esophageal and gastric cancers, but evidence from large, well-controlled datasets has been limited. 

“Cancer rates in women increase significantly after age of 60, so it has been hypothesized that this pattern is linked to declined levels of estrogen that comes with menopause,” said Wocalewski, explaining the rationale for the study.

“Some studies looking at MHT use have indicated a possible protective effect, but with some contradictory results and type-specific variations,” Wocalewski noted. “Our study aimed to investigate these previous findings using a larger study sample.”

The population-based case-control study drew on prospectively collected data from the NordGETS database including national prescription, cancer, and population registries in Denmark, Finland, Iceland, Norway, and Sweden spanning 1994-2020. In total, 19,518 women with esophago-gastric cancer were compared with 195,094 controls randomly selected from the general population, and matched for age, calendar year, and country (in a 1:10 ratio). Women were 45 years or over with a diagnosis of EAC, ESCC, or GAC. 

In total there were 5000 cases of EAC, 4401 of ESCC, and 10,117 of GAC, with the median ages being 74, 72, and 75 years, respectively; most cases of EAC and ESCC were found in Denmark, and most cases of GAC were in Sweden. 

The investigators categorized participants by defined daily doses (DDDs) of MHT into three equal sized categories: low (< 158 DDDs), intermediate (158-848 DDDs), and high (> 848 DDDs). MHT was defined as systemic or local, and estrogen only or combined with progesterone. Odds ratios (ORs) were calculated for three major cancer outcomes of EAC, ESCC, and GAC, adjusted for known confounders such as age, obesity, smoking, alcohol consumption, reflux disease, Helicobacter pylori eradication, and concomitant use of statins or non-steroidal anti-inflammatory drugs (NSAIDs). However, Wocalewski noted that they did not adjust for socio-economic factors. 

 

Significant Reductions Across Esophago-Gastric Cancers

Compared with nonusers, women with any MHT exposure had a markedly reduced risk of EAC with adjusted ORs (aORs) of 0.74 (95% CI, 0.67-0.81) for low-use, 0.68 (95% CI, 0.61-0.75) for intermediate-use, and 0.68 (95% CI, 0.61-0.75) for high-use groups. Various adjustments were made for obesity, reflux, statins, and NSAIDs, as well as smoking, alcohol use, and H pylori eradication.

Similar inverse associations were seen for ESCC with aORs of 0.69 (95% CI, 0.62-0.77), 0.70 (95% CI, 0.62-0.77), and 0.71 (95% CI, 0.64-0.79) across the dose categories, and for GAC where risk decreased progressively from 0.90 (95% CI, 0.84-0.96) to 0.80 (95% CI, 0.74-0.86) across increasing MHT doses.

When stratified by hormone formulation, combined estrogen-progesterone therapy and systemic MHT conferred the strongest risk reduction. For example, systemic MHT use was associated with aORs of 0.67 (95% CI, 0.61-0.74) for EAC and 0.82 (95% CI, 0.76-0.88) for GAC, while local (vaginal) preparations showed slightly weaker associations at 0.72 (95% CI, 0.66-0.78) and 0.87 (95% CI, 0.83-0.92), respectively. 

In EAC, combined estrogen-progesterone therapy led to an OR of 0.68 (95% CI, 0.63-0.73) and 0.77 (95% CI, 0.69-0.87) for women on estrogen alone. Similar results were found for ESCC. For GAC, combination resulted in an aOR of 0.85 (95% CI, 0.80-0.89) and 0.88 (95% CI, 0.81-0.97) in estrogen only therapy respectively.

“Our results reinforce the concept that estrogenic signaling may influence tumor development in the upper GI tract,” said Wocalewski. “Understanding these mechanisms could help identify at-risk populations and inform prevention strategies,” she added, noting that, “hormonal effects on epithelial tight junctions and nitric oxide synthesis in the gastrointestinal tract” would have an influence on smooth muscle cells.

 

Link Between Hormones and GI Pathology

Commenting on the study for GI & Hepatology News, Jan Bornschein, MD, University of Oxford, UK, who was not involved in the research, said the results are “highly relevant.” 

“We’ve seen for a long time a link between hormones and GI pathology, however, it has been poorly investigated and the whole mechanisms are not understood, so it’s welcome that this group is moving forward and investigating this in a structured way,” he said.

Another delegate cautioned that MHT was associated with a risk for other non- gastrointestinal cancers. “I think it’s extremely important, because there are data on associations [of MHT] with breast cancer and also endometrial cancer. It’s good to see that it may help and reduce this cancer, but we have to be really careful about the others.”

Wocalewski reports no relevant conflicts of interest. Bornschein has no disclosures relevant to this study. The study was funded by Karolinska Institutet and supported by national cancer and prescription registry data from Denmark, Finland, Iceland, Norway, and Sweden.

 

A version of this article appeared on Medscape.com.

BERLIN — Women who use menopausal hormone therapy (MHT; ie, hormone replacement therapy ) have an up to 30% reduction in the risk of developing esophageal and gastric cancers compared to nonusers, according to a large population-based study across five Nordic countries. The association appeared strongest for combined estrogen-progestin and systemic formulations.

“This is one of the largest and most comprehensive studies to date supporting the hypothesis of an inverse association between MHT and risk of esophago-gastric cancer,” said Victoria Wocalewski, MD, from the Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, who presented the findings at United European Gastroenterology (UEG) Week 2025. 

There was a decreased risk for all investigated cancers in MHT users, but the strongest association was observed for esophageal adenocarcinoma (EAC), said Wocalewski. In addition, “there were discrete dose-dependent results for [EAC] and gastric adenocarcinoma (GAC) but not for esophageal squamous cell carcinoma (ESCC).”

 

Large Population-Based Study 

Previous research has suggested that hormonal changes could partly explain the male predominance in esophageal and gastric cancers, but evidence from large, well-controlled datasets has been limited. 

“Cancer rates in women increase significantly after age of 60, so it has been hypothesized that this pattern is linked to declined levels of estrogen that comes with menopause,” said Wocalewski, explaining the rationale for the study.

“Some studies looking at MHT use have indicated a possible protective effect, but with some contradictory results and type-specific variations,” Wocalewski noted. “Our study aimed to investigate these previous findings using a larger study sample.”

The population-based case-control study drew on prospectively collected data from the NordGETS database including national prescription, cancer, and population registries in Denmark, Finland, Iceland, Norway, and Sweden spanning 1994-2020. In total, 19,518 women with esophago-gastric cancer were compared with 195,094 controls randomly selected from the general population, and matched for age, calendar year, and country (in a 1:10 ratio). Women were 45 years or over with a diagnosis of EAC, ESCC, or GAC. 

In total there were 5000 cases of EAC, 4401 of ESCC, and 10,117 of GAC, with the median ages being 74, 72, and 75 years, respectively; most cases of EAC and ESCC were found in Denmark, and most cases of GAC were in Sweden. 

The investigators categorized participants by defined daily doses (DDDs) of MHT into three equal sized categories: low (< 158 DDDs), intermediate (158-848 DDDs), and high (> 848 DDDs). MHT was defined as systemic or local, and estrogen only or combined with progesterone. Odds ratios (ORs) were calculated for three major cancer outcomes of EAC, ESCC, and GAC, adjusted for known confounders such as age, obesity, smoking, alcohol consumption, reflux disease, Helicobacter pylori eradication, and concomitant use of statins or non-steroidal anti-inflammatory drugs (NSAIDs). However, Wocalewski noted that they did not adjust for socio-economic factors. 

 

Significant Reductions Across Esophago-Gastric Cancers

Compared with nonusers, women with any MHT exposure had a markedly reduced risk of EAC with adjusted ORs (aORs) of 0.74 (95% CI, 0.67-0.81) for low-use, 0.68 (95% CI, 0.61-0.75) for intermediate-use, and 0.68 (95% CI, 0.61-0.75) for high-use groups. Various adjustments were made for obesity, reflux, statins, and NSAIDs, as well as smoking, alcohol use, and H pylori eradication.

Similar inverse associations were seen for ESCC with aORs of 0.69 (95% CI, 0.62-0.77), 0.70 (95% CI, 0.62-0.77), and 0.71 (95% CI, 0.64-0.79) across the dose categories, and for GAC where risk decreased progressively from 0.90 (95% CI, 0.84-0.96) to 0.80 (95% CI, 0.74-0.86) across increasing MHT doses.

When stratified by hormone formulation, combined estrogen-progesterone therapy and systemic MHT conferred the strongest risk reduction. For example, systemic MHT use was associated with aORs of 0.67 (95% CI, 0.61-0.74) for EAC and 0.82 (95% CI, 0.76-0.88) for GAC, while local (vaginal) preparations showed slightly weaker associations at 0.72 (95% CI, 0.66-0.78) and 0.87 (95% CI, 0.83-0.92), respectively. 

In EAC, combined estrogen-progesterone therapy led to an OR of 0.68 (95% CI, 0.63-0.73) and 0.77 (95% CI, 0.69-0.87) for women on estrogen alone. Similar results were found for ESCC. For GAC, combination resulted in an aOR of 0.85 (95% CI, 0.80-0.89) and 0.88 (95% CI, 0.81-0.97) in estrogen only therapy respectively.

“Our results reinforce the concept that estrogenic signaling may influence tumor development in the upper GI tract,” said Wocalewski. “Understanding these mechanisms could help identify at-risk populations and inform prevention strategies,” she added, noting that, “hormonal effects on epithelial tight junctions and nitric oxide synthesis in the gastrointestinal tract” would have an influence on smooth muscle cells.

 

Link Between Hormones and GI Pathology

Commenting on the study for GI & Hepatology News, Jan Bornschein, MD, University of Oxford, UK, who was not involved in the research, said the results are “highly relevant.” 

“We’ve seen for a long time a link between hormones and GI pathology, however, it has been poorly investigated and the whole mechanisms are not understood, so it’s welcome that this group is moving forward and investigating this in a structured way,” he said.

Another delegate cautioned that MHT was associated with a risk for other non- gastrointestinal cancers. “I think it’s extremely important, because there are data on associations [of MHT] with breast cancer and also endometrial cancer. It’s good to see that it may help and reduce this cancer, but we have to be really careful about the others.”

Wocalewski reports no relevant conflicts of interest. Bornschein has no disclosures relevant to this study. The study was funded by Karolinska Institutet and supported by national cancer and prescription registry data from Denmark, Finland, Iceland, Norway, and Sweden.

 

A version of this article appeared on Medscape.com.

The FDA approved the TNF-alpha inhibitor golimumab (Simponi, Johnson & Johnson) to treat children with moderately to severely active ulcerative colitis (UC) weighing at least 15 kg. 

Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval. 

The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC. 

In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.

The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab. 

Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.

Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said. 

The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.

Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.

This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC. 

Full prescribing information and medication guide is available online.

A version of this article first appeared on Medscape.com.

The FDA approved the TNF-alpha inhibitor golimumab (Simponi, Johnson & Johnson) to treat children with moderately to severely active ulcerative colitis (UC) weighing at least 15 kg. 

Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval. 

The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC. 

In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.

The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab. 

Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.

Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said. 

The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.

Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.

This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC. 

Full prescribing information and medication guide is available online.

A version of this article first appeared on Medscape.com.

The FDA approved the TNF-alpha inhibitor golimumab (Simponi, Johnson & Johnson) to treat children with moderately to severely active ulcerative colitis (UC) weighing at least 15 kg. 

Of the more than 1 million people in the US living with UC, roughly 20% are children, Johnson & Johnson noted in a statement announcing approval. 

The pediatric indication for golimumab in UC was supported by the open-label PURSUIT 2 phase 3 study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered golimumab in children aged 2 years and older with moderately to severely active UC. 

In the trial, the primary endpoint of clinical remission at week 6 was achieved by 32% of children. Clinical remission was defined as a Mayo score ≤ 2 points, with no individual subscore > 1.

The secondary endpoints of clinical response at week 6 was achieved by 58%, and endoscopic improvement at week 6 was achieved by 40% of patients receiving golimumab. 

Clinical response was defined as a decrease from baseline in the Mayo score by > 30% and > 3 points, with either a decrease from baseline in the rectal bleeding subscore of > 1 or a rectal bleeding subscore of 0 or 1. Endoscopic remission was defined as an endoscopy subscore of 0 or 1 based on local endoscopy.

Among children treated with golimumab who were in clinical remission at 6 weeks, 57% maintained clinical remission of symptoms at week 54. Safety results in children were consistent with clinical trials of golimumab in adults with UC, the company said. 

The recommended dose of golimumab for pediatric patients weighing at least 40 kg is 200 mg at week 0, followed by 100 mg at weeks 2, 6, and every 4 weeks thereafter; for those weighing at least 15 kg to less than 40 kg, golimumab is administered at 100 mg at week 0, followed by 50 mg at weeks 2, 6, and every 4 weeks thereafter.

Golimumab is administered as a prefilled syringe; children aged 12 and older can self-administer it after proper training by a healthcare provider.

This is the first pediatric approval for golimumab, which is already approved for four indications, including adults living with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active UC. 

Full prescribing information and medication guide is available online.

A version of this article first appeared on Medscape.com.

The benefits of many elective nonhepatic surgeries outweigh the risks for select patients with compensated cirrhosis, but those at high risk for poor surgical outcomes should continue to seek alternatives to surgery, according to an updated guideline from the American College of Gastroenterology.

Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology. 

“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.

“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.

The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.

Three conditional recommendations:

• For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
• For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
• For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.

The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis. 

 

What’s New and Notable?

New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.

The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.

Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.

“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.

These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.

 

Tackling Clinical Challenges

The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.

“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.

“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.

For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.

The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose. 

 

A version of this article appeared on Medscape.com

The benefits of many elective nonhepatic surgeries outweigh the risks for select patients with compensated cirrhosis, but those at high risk for poor surgical outcomes should continue to seek alternatives to surgery, according to an updated guideline from the American College of Gastroenterology.

Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology. 

“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.

“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.

The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.

Three conditional recommendations:

• For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
• For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
• For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.

The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis. 

 

What’s New and Notable?

New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.

The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.

Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.

“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.

These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.

 

Tackling Clinical Challenges

The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.

“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.

“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.

For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.

The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose. 

 

A version of this article appeared on Medscape.com

The benefits of many elective nonhepatic surgeries outweigh the risks for select patients with compensated cirrhosis, but those at high risk for poor surgical outcomes should continue to seek alternatives to surgery, according to an updated guideline from the American College of Gastroenterology.

Procedures such as cholecystectomy and hernia repair can be safely performed if precautions are taken, but surgical decision-making in patients with cirrhosis calls for a nuanced approach that takes into account several factors, including severity of liver disease, nonhepatic comorbidities, and procedure-specific considerations, wrote lead author Nadim Mahmud, MD, assistant professor of medicine and epidemiology at the Perelman School of Medicine, University of Pennsylvania, Philadelphia, and colleagues, in the American Journal of Gastroenterology. 

“Patients with cirrhosis face substantially higher risks from surgery than those without liver disease, and careful guidance and risk stratification are essential,” Mahmud told GI & Hepatology News.

“At the same time, more patients are living longer with cirrhosis and increasingly require nonhepatic surgeries. Clinicians need up-to-date, practical recommendations that go beyond liver scores alone by integrating liver disease severity, comorbidities, and procedure-specific risk,” Mahmud said. The new guideline provides a comprehensive framework to help ensure that patients with cirrhosis undergo necessary operations, while managing preventable complications, he explained.

The guideline includes four recommendations for preoperative care, of which three are conditional and one is strong. The strong recommendation calls for the use of thrombopoietin receptor agonists, dosed according to baseline platelet count, in patients with cirrhosis and severe thrombocytopenia who are undergoing invasive procedures to reduce the need for perioperative transfusions and potentially reduce the risk for periprocedural bleeding.

Three conditional recommendations:

• For patients with compensated cirrhosis and unclear presence of clinically significant portal hypertension (CSPH), preoperative liver stiffness measurement and platelet count assessment are recommended to determine whether CSPH is present due to increased perioperative risks associated with the condition. Cross-sectional imaging should be conducted to identify portosystemic collaterals and complications of portal hypertension.
• For patients with cirrhosis and CSPH with alternative indications for transjugular intrahepatic portosystemic shunt (TIPS), such as large varices or refractory ascites, preoperative TIPS is suggested to reduce postoperative morbidity and mortality attributable to portal hypertension.
• For patients with cirrhosis undergoing major hepatic surgery, referral to a high-volume liver surgery or transplant center, when feasible, is recommended.

The guideline also advises on 26 key concepts, including nutrition, alcohol and tobacco use, comorbidities such as frailty and sarcopenia, and preoperative treatment of liver disease drivers such as hepatitis B, hepatitis C, and autoimmune hepatitis. 

 

What’s New and Notable?

New elements of the guideline include use of cirrhosis-specific risk calculators, especially the Veterans Outcomes and Costs Associated with Liver disease (VOCAL)-Penn Score, to estimate operative risk and facilitate shared decision-making regarding surgery. The VOCAL-Penn Score, developed by Mahmud and colleagues at the University of Pennsylvania, incorporates surgery type and has shown superiority to older tools that often overestimate risk, Mahmud told GI & Hepatology News.

The guideline highlights standardized assessment of portal hypertension using noninvasive liver stiffness measurement plus platelet count and imaging, Mahmud said. “The guideline also underscores the importance of considering liver transplant evaluation before surgery in higher-risk patients,” he noted.

Clinicians will find clear recommendations on optimizing the perioperative period through nutritional support and structured prehabilitation, as well as the use of viscoelastic testing to guide transfusion decisions and the use of thrombopoietin-receptor agonists for severe thrombocytopenia, he added.

“Importantly, in carefully selected patients with significant portal hypertension, a preoperative transjugular intrahepatic portosystemic shunt may be reasonable, though it is not recommended broadly,” Mahmud said. “Finally, procedure-specific guidance, such as elective hernia repair after ascites control, laparoscopic cholecystectomy in well-compensated cirrhosis, and sleeve gastrectomy as the bariatric procedure of choice, helps translate risk into action,” he said.

These elements address key challenges in managing perioperative risk in patients with cirrhosis, namely miscalibrated risk estimates, inconsistent portal hypertension assessment, hemostasis management, and wide variation in practice, Mahmud noted.

 

Tackling Clinical Challenges

The new guideline collates the latest evidence and assessment tools to provide practical advice for clinicians to not only estimate risk but also better prepare patients with cirrhosis for surgical procedures, Peter D. Block, MD, assistant professor of medicine in the section of digestive diseases at the Yale School of Medicine, New Haven, Connecticut, told GI & Hepatology News.

“The larger and more invasive the operation, the higher the risk,” said Block, who was not involved in writing the guideline. Surgeries associated with the highest risk for patients with cirrhosis include major open abdominal operations, chest or cardiothoracic surgery, and major vascular surgeries, as well as emergency operations, for which there is less time to optimize any liver-related problems in advance, he said.

“Cirrhosis affects clotting, fluid balance, immunity, kidney function, and medication clearance, and each of these factors influence surgical risk,” Block said. “The guideline recommends combining liver-specific risk assessment scores with surgery-specific factors and clinical judgement, rather than relying on a single test,” he noted.

For elective surgeries, “the guideline provides practical pathways for when and how to optimize first, and when surgery must proceed despite higher risk,” he said.

The guideline was supported by the American College of Gastroenterology. Mahmud disclosed receiving research support from the National Institute of Diabetes and Digestive and Kidney Diseases and investigator-initiated research funding from Grifols, unrelated to the guideline. Block had no financial conflicts to disclose. 

 

A version of this article appeared on Medscape.com