Clinical Gastroenterology and Hepatology最新文献

{"title":"Functional Lumen Imaging Probe Provides an Accurate Assessment of Esophageal Diameter in Patients With Eosinophilic Esophagitis.","authors":"Ronak V Patel, Dustin A Carlson, Angelika Zalewski, Nirmala Gonsalves, John Pandolfino, Ikuo Hirano","doi":"10.1016/j.cgh.2024.10.032","DOIUrl":"10.1016/j.cgh.2024.10.032","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomized Phase II Study of Efmarodocokin Alfa, an interleukin-22 Agonist, Versus Vedolizumab in Patients With Ulcerative Colitis.","authors":"Silvio Danese, Michael E Rothenberg, Jeremy J Lim, Han Ting Ding, Jacqueline M McBride, Yiling Chen, Ajit Dash, Jordan S Mar, Mary Keir, Laurent Peyrin-Biroulet, Julian Panes, Jean-Frederic Colombel, Brian Feagan, John F Valentine, Stefan Schreiber","doi":"10.1016/j.cgh.2024.11.013","DOIUrl":"10.1016/j.cgh.2024.11.013","url":null,"abstract":"<p><strong>Background & aims: </strong>Efmarodocokin alfa is an interleukin (IL)-22 agonist, with favorable pharmacokinetic properties and an acceptable safety profile. This study further explored the therapeutic potential of efmarodocokin alfa compared with vedolizumab in patients with ulcerative colitis (UC).</p><p><strong>Methods: </strong>This randomized phase II trial evaluated the efficacy, safety, pharmacokinetics, and pharmacodynamics of 3 doses of efmarodocokin alfa administered intravenously every 4 weeks (30 μg/kg [n = 43], 60 μg/kg [n = 44], and 90 μg/kg [n = 43]) compared with placebo (n = 22) and with vedolizumab (n = 43) in the treatment of moderate to severe UC. Key clinical outcomes were assessed through the modified Mayo Clinic Score, and endoscopic evaluations by a central reader.</p><p><strong>Results: </strong>Efmarodocokin alfa was adequately tolerated with an acceptable safety profile. Although efmarodocokin alfa did not show statistically significant improvement in clinical remission, clinical response, endoscopic healing, or endoscopic remission at week 8 compared with placebo, vedolizumab demonstrated some efficacy. Clinical remission was achieved by 12%, 9%, and 12% of patients in the 30, 60, and 90 μg/kg dose arms, respectively, compared with 9% and 26% of patients in the placebo and vedolizumab arms at week 8. Similarly, endoscopic healing at week 8 was achieved by 14%, 14%, and 12% of patients in the 30, 60, and 90 μg/kg dose arms, respectively, compared with 14% and 33% of patients in the placebo and vedolizumab arms. A dose-dependent increase in pharmacodynamic biomarkers was observed (regenerating islet-derived protein 3-alpha and C-reactive protein levels).</p><p><strong>Conclusion: </strong>Efmarodocokin alfa did not demonstrate efficacy compared with placebo, and this phase II study was ended early for futility; however, there was evidence of target engagement (skin adverse events, regenerating islet-derived protein 3-alpha levels).</p><p><strong>Clinicaltrials: </strong>gov, Number: NCT03558152.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Temporal Changes in Risk Factors of Hepatocellular Carcinoma in a Prospective Cirrhosis Cohort.","authors":"George Cholankeril, Aaron P Thrift, Saira Khaderi, Fasiha Kanwal, Hashem B El-Serag, Hao Duong, Amit G Singal, Sumeet K Asrani, Themistoklis Kourkompetis, Asif Zamir, Jorge A Marrero, Ruben Hernaez, Michelle Luster, Abeer Al-Sarraj, Emad Salem","doi":"10.1016/j.cgh.2024.11.012","DOIUrl":"10.1016/j.cgh.2024.11.012","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the Quality of Artificial Intelligence Responses and Resistance to Sycophancy in Providing Patient-centered Medical Advice on Gastroesophageal Reflux Disease.","authors":"Benjamin Douglas Liu, Steve D'Souza, Melina Roy, Metrohealth Dietitians, Sherif Saleh, Ronnie Fass, Gengqing Song","doi":"10.1016/j.cgh.2024.10.033","DOIUrl":"10.1016/j.cgh.2024.10.033","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to \"Kidney Failure, Inflammatory Bowel Disease and Colectomy \".","authors":"Yuanhang Yang, Juan J Carrero","doi":"10.1016/j.cgh.2024.12.001","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.12.001","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Unusual Case of Multiple Gastric Masses: Granulocytic Sarcoma.","authors":"Ming Zhou, Fu Guan","doi":"10.1016/j.cgh.2024.11.018","DOIUrl":"10.1016/j.cgh.2024.11.018","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Elusive Pancreatic Mass.","authors":"Kosaku Morimoto, Kazuyuki Matsumoto, Ryuta Takenaka","doi":"10.1016/j.cgh.2024.11.016","DOIUrl":"10.1016/j.cgh.2024.11.016","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Validation and Epidemiologic Definition of the Novel Steatotic Liver Disease Nomenclature in a National United States Cohort With Cirrhosis.","authors":"Catherine Mezzacappa, Pedro Ochoa-Allemant, Marina Serper, Tamar H Taddei, Binu V John, David E Kaplan, Nadim Mahmud","doi":"10.1016/j.cgh.2024.10.035","DOIUrl":"10.1016/j.cgh.2024.10.035","url":null,"abstract":"<p><strong>Background & aims: </strong>Novel steatotic liver disease (SLD) definitions were introduced in 2023. Accurate and meaningful classifications using clinical data are needed to study interventions and outcomes.</p><p><strong>Methods: </strong>In a national cohort of Veterans with cirrhosis and imaging-confirmed steatosis, 7 algorithms differentially emphasizing cardiometabolic risk factors (CMRFs) and alcohol exposure were developed to define alcohol-associated liver disease (ALD), metabolic dysfunction associated SLD (MASLD), and MASLD with increased alcohol intake (MetALD). The primary outcome was classification of SLD, which was validated using hospitalizations for major acute cardiac events (MACE) and alcohol use disorder (AUD). Secondary outcomes included longitudinal Child-Turcotte-Pugh class, incident hepatocellular carcinoma, and all-cause mortality.</p><p><strong>Results: </strong>In all, 31,514 patients with cirrhosis (median age 64 years) were included. CMRFs (98.8% ≥ 1) and hazardous alcohol use (65.3%) were highly prevalent. The distributions of MASLD, MetALD, and ALD varied substantially across classification methods with varying CMRF and alcohol criteria. For example, MetALD ranged from 4.7% to 47.2%. Using method 4, incidence rates of MACE hospitalizations in MASLD, MetALD, and ALD were 16.7, 14.5, and 8.4 per 100 person-years, respectively, and incidence rates of AUD hospitalizations were 2.0, 26.1, and 47.6 per 100 person-years, respectively. Hypertriglyceridemia and low high-density lipoprotein were common across SLD subtypes, including ALD (67.3% hypertriglyceridemia; 48.2% low high-density lipoprotein). Patients with ALD (hazard ratio, 1.41; 95% confidence interval, 1.34-1.48) had significantly higher hazards of mortality relative to MASLD.</p><p><strong>Conclusion: </strong>Classification of SLD is highly sensitive to relative weighting of CMRFs and alcohol use. Clinically relevant definitions should consider data availability on alcohol and the limitations of lipid measurements in distinguishing SLD subtypes.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hepatic Artery Pseudoaneurysm After Whipple Procedure.","authors":"Hailin Yan, Jinlin Yang, Xue Xiao","doi":"10.1016/j.cgh.2024.11.017","DOIUrl":"10.1016/j.cgh.2024.11.017","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142845839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acute Severe Ulcerative Colitis: An International Delphi Consensus on Clinical Trial Design and Endpoints.","authors":"Sailish Honap, Vipul Jairath, Bruce E Sands, Parambir S Dulai, Peter D R Higgins, Peter De Cruz, Ana Gutiérrez, Paulo G Kotze, Byong Duk Ye, Taku Kobayashi, Richard B Gearry, Pablo A Olivera, Aurélien Amiot, Mahmoud H Mosli, Sameer Al Awadhi, Jonas Halfvarson, Kamal V Patel, Shaji Sebastian, Silvio Danese, Laurent Peyrin-Biroulet","doi":"10.1016/j.cgh.2024.10.029","DOIUrl":"10.1016/j.cgh.2024.10.029","url":null,"abstract":"<p><strong>Background & aims: </strong>Interventional clinical trials in acute severe ulcerative colitis (ASUC) are characterized by substantial heterogeneity due to a lack of consensus in several key areas of trial design-this impedes clinical research efforts to identify novel therapies. The objective of this initiative was to achieve the first consensus and provide clear position statements on ASUC trial design.</p><p><strong>Methods: </strong>A modified Delphi consensus approach was employed with a panel of 20 clinicians with international representation and expertise in ASUC trial design and delivery. Agreement was defined as at least 75% of participants voting as \"agree\" with each statement.</p><p><strong>Results: </strong>In total, 30 statements achieved consensus and were approved. Statements centred on proposing suitable eligibility criteria (disease extent, disease severity, prior therapy exposure), optimizing trial design (randomization, stratification, corticosteroid handling, timing of assessments), and recommending primary and secondary endpoints alongside defining key efficacy outcomes (clinical and endoscopic response and remission, treatment failure, quality of life).</p><p><strong>Conclusions: </strong>The expansion of drugs to treat moderate-severe ulcerative colitis over the past decade, particularly the rapidly acting Janus kinase inhibitors, is promising and has reignited the interest in identifying suitable therapeutic candidates for ASUC. Clinical trials in this high-risk population are challenging to conduct and this consensus provides a framework for future trials to advance drug development.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2024-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}