Clinical Gastroenterology and Hepatology最新文献

{"title":"Baseline and Dynamic MAF-5 Score to Predict Liver Fibrosis and Liver-Related Events in General Population With MASLD","authors":"Shanghao Liu , Xuanwei Jiang , Junliang Fu, Vincent Wai-Sun Wong, Victor W. Zhong, Xiaolong Qi","doi":"10.1016/j.cgh.2024.07.005","DOIUrl":"10.1016/j.cgh.2024.07.005","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 365-368.e3"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874297","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":"The Future of Clinical Trials in Inflammatory Bowel Disease","authors":"Christopher Ma ,&nbsp;Virginia Solitano ,&nbsp;Silvio Danese ,&nbsp;Vipul Jairath","doi":"10.1016/j.cgh.2024.06.036","DOIUrl":"10.1016/j.cgh.2024.06.036","url":null,"abstract":"<div><div>The medical management of inflammatory bowel disease (IBD) has been transformed over the past few decades by the approval of multiple classes of advanced therapies and the integration of more targeted treatment strategies for Crohn’s disease and ulcerative colitis. These changes have been driven by an increasing number of pivotal randomized controlled trials, which have grown in size and complexity over time. Several landmark studies that are anticipated to change current IBD management paradigms have recently been completed or are on-going, including the first head-to-head biologic trials, advanced combination treatment trials, therapeutic strategy and treatment target trials, and multiple phase 3 registrational programs of novel compounds. Despite these advances, the future of IBD trials also faces major challenges with respect to cost, feasibility, and recruitment. Accordingly, innovative methods for early and late phase randomized controlled trials must be adopted. In this review, we provide a comprehensive overview of the evolution of modern IBD trials, discuss methods for improving trial efficiency in early and late phase development, and provide insights into the interpretation and implications of these data for clinical care.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 3","pages":"Pages 480-489"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141723226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MetALD: The Outcome of Living Under the Shadow of Alcohol for 4 Decades","authors":"Nahum Méndez-Sánchez,&nbsp;Mariana M. Ramírez-Mejía","doi":"10.1016/j.cgh.2024.05.009","DOIUrl":"10.1016/j.cgh.2024.05.009","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 377-378"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141080740","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":"FODMAPs in IBS: Revisiting Restriction","authors":"Andrea Shin","doi":"10.1016/j.cgh.2024.06.019","DOIUrl":"10.1016/j.cgh.2024.06.019","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 222-224"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141497296","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":"Setting a Value for Novel GERD Treatments","authors":"Fouad Otaki,&nbsp;John O. Clarke","doi":"10.1016/j.cgh.2024.06.039","DOIUrl":"10.1016/j.cgh.2024.06.039","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 220-221"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619475","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":"Endoscopic, Histologic, and Composite Endpoints in Patients With Ulcerative Colitis Treated With Etrasimod","authors":"Fernando Magro ,&nbsp;Laurent Peyrin-Biroulet ,&nbsp;Bruce E. Sands ,&nbsp;Silvio Danese ,&nbsp;Vipul Jairath ,&nbsp;Martina Goetsch ,&nbsp;Abhishek Bhattacharjee ,&nbsp;Joseph Wu ,&nbsp;Diogo Branquinho ,&nbsp;Irene Modesto ,&nbsp;Brian G. Feagan","doi":"10.1016/j.cgh.2024.07.010","DOIUrl":"10.1016/j.cgh.2024.07.010","url":null,"abstract":"<div><h3>Background &amp; Aims</h3><div>Histologic remission, a potentially important treatment target in ulcerative colitis (UC), is associated with favorable long-term outcomes. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)_1,4,5 receptor modulator for the treatment of moderately to severely active UC. This post-hoc analysis of the ELEVATE UC program evaluated the efficacy of etrasimod according to histologic and composite (histologic/endoscopic/symptomatic) endpoints and examined their prognostic value.</div></div><div><h3>Methods</h3><div>Patients with moderately to severely active UC were randomized 2:1 to once-daily oral etrasimod 2 mg or placebo. Histologic and composite endpoints, including disease clearance (endoscopic/histologic/symptomatic remission), were assessed at Weeks 12 (ELEVATE UC 52; ELEVATE UC 12) and 52 (ELEVATE UC 52). Logistic regressions examined associations between baseline and Week 12 histologic/composite endpoints and Week 52 outcomes.</div></div><div><h3>Results</h3><div>At Weeks 12 and 52, significant improvements with etrasimod vs placebo were observed in histologic/composite outcomes, including endoscopic improvement-histologic remission and disease clearance. The proportion of patients treated with etrasimod achieving clinical remission at Week 52 was higher among those with disease clearance at Week 12 vs those without disease clearance (73.9% [17/23] vs 28.3% [71/251]). Histologic improvement and endoscopic improvement at Week 12 were moderately and strongly associated with clinical remission at Week 52 (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.27–4.41; and OR, 6.36; 95% CI, 3.47–11.64, respectively). Histologic remission and endoscopic improvement at Week 12 were strongly associated with endoscopic improvement-histologic remission at Week 52 (OR, 3.21; 95% CI, 1.70–6.06 and OR, 5.47; 95% CI, 2.89–10.36, respectively).</div></div><div><h3>Conclusions</h3><div>Etrasimod was superior to placebo for achievement of stringent histologic and composite endpoints.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, Number: <span><span>NCT03945188</span><svg><path></path></svg></span>; <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, Number: <span><span>NCT03996369</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":"23 2","pages":"Pages 341-350.e6"},"PeriodicalIF":11.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874343","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Colorectal Cancer Incidence in Steatotic Liver Disease (MASLD, MetALD, and ALD).","authors":"Takefumi Kimura, Nobuharu Tamaki, Shun-Ichi Wakabayashi, Naoki Tanaka, Takeji Umemura, Namiki Izumi, Rohit Loomba, Masayuki Kurosaki","doi":"10.1016/j.cgh.2024.12.018","DOIUrl":"10.1016/j.cgh.2024.12.018","url":null,"abstract":"<p><strong>Background and aims: </strong>Obesity and alcohol consumption are established risk factors for colorectal cancer (CRC). Recently, a multisociety consensus group has introduced a new classification for steatotic liver disease (SLD), which encompasses metabolic dysfunction-associated steatotic liver disease (MASLD), MASLD and increased alcohol intake (MetALD), and alcohol-associated liver disease (ALD). However, the risk of developing CRC in each of these SLD subgroups is unknown. This nationwide cohort study investigated the risk of CRC in MASLD, MetALD, and ALD patients. The primary endpoint was the occurrence of CRC in each SLD subgroup.</p><p><strong>Methods: </strong>We conducted a nationwide, population-based study that included 1,497,813 patients diagnosed with MASLD, MetALD, or ALD, alongside 4,885,536 individuals with no known liver disease as a comparison group. The primary outcome was the incidence of CRC and the risk of CRC was compared between MASLD, MetALD and ALD.</p><p><strong>Results: </strong>The 5- and 10-year cumulative CRC incidence rates were 0.22% and 0.48% for MASLD, 0.32% and 0.73% for MetALD, and 0.43% and 0.97% for ALD, and 0.15% and 0.31% for the comparison group, respectively. The cumulative incidence of CRC was highest for ALD and significantly greater than that for MetALD, MASLD, and the comparison group (both P < .001). Using the comparison group as the reference and adjusting for age, sex, smoking habit, number of colorectal examinations, diabetes mellitus, dyslipidemia, hypertension, and medication use, the adjusted hazard ratios for CRC were 1.73 (95% CI, 1.59-1.87) for ALD, 1.36 (95% CI, 1.28-1.45) for MetALD, and 1.28 (95% CI, 1.22-1.35) for MASLD.</p><p><strong>Conclusions: </strong>The risk of CRC differs significantly among patients with SLD, with the highest incidence observed in those with ALD, followed by MetALD and MASLD.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074043","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":"The Assessment of Gastrointestinal Transit by the Atmo Capsule: A Comparison With the SmartPill Capsule.","authors":"Braden Kuo, Allen A Lee, Thomas Abell, Ashok Attaluri, Michael Cline, William Hasler, Vincent Ho, Anthony Lembo, Amir Masoud, Richard McCallum, Baharak Moshiree, Eamonn M M Quigley, Satish S C Rao, Abigail Stocker, Mayra Sanchez, Irene Sarosiek, Brian Surjanhata, Jerry Zhou, William D Chey","doi":"10.1016/j.cgh.2024.12.013","DOIUrl":"10.1016/j.cgh.2024.12.013","url":null,"abstract":"<p><strong>Background & aims: </strong>Wireless motility capsules (WMCs) can be used to assess gastrointestinal transit time to facilitate diagnosis and treatment of motility disorders. The Atmo Capsule is a novel WMC that measures gases (H₂, CO₂, O₂) and temperature. We aimed to compare and evaluate the performance characteristics of the Atmo Capsule and the SmartPill Capsule (discontinued reference standard WMC) for measurement of gastric emptying time (GET) and colonic transit time (CTT) in patients with confirmed or suspected disordered gastrointestinal transit.</p><p><strong>Methods: </strong>Patients with symptoms indicative of an upper and/or lower gastrointestinal motility disorder ingested the 2 WMCs in a random order. Gastrointestinal transit times were assessed using Spearman correlation and Bland-Altman analysis. Device agreement was assessed for delayed GET (≥5 hours) and CTT (≥59 hours).</p><p><strong>Results: </strong>There were 213 participants from 12 sites, yielding 177 paired GET and 147 paired CTT measurements. The measurements for GET and CTT with the Atmo Capsule and SmartPill Capsule were strongly correlated (GET, R = 0.73, P < .01; CTT, R = 0.69, P < .01), and their observed biases were within 10% of the delayed transit margin. Both delayed GET (68/177) and CTT (56/147) were identified in 38% of participants, with 84% agreement for identification of both delayed GET (sensitivity 78%, specificity 86%) and CTT (sensitivity 67%, specificity 93%). No serious adverse device effects were reported.</p><p><strong>Conclusions: </strong>The performance characteristics of the Atmo capsule for measurements of GET and CTT were equivalent to the reference standard WMC with a strong correlation and good device agreement. These results demonstrate that the Atmo Capsule is a valid method for evaluating gastrointestinal transit.</p><p><strong>Clinicaltrials: </strong>gov number, NCT05718505.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074029","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":"Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Correlates with Clinical Parameters and Liver Histology.","authors":"Jennifer M Kolb, Marc Monachese, Raymond A Rubin, Thomas J Wang, Alyssa Choi, Ahmad N Bazarbashi, Bhaumik Brahmbhatt, Ali Zakaria, Pedro Cortes, Varun Kesar, William F Abel, Wen-Pin Chen, Christine McLaren, Amirali Tavangar, Amit G Singal, Pushpak Taunk, Michael B Wallace, Prashant Kedia, David Lee, Ali Abbas, Paul Yeaton, Natalie Cosgrove, Vivek Kesar, Kenneth J Chang, Marvin Ryou, Jason Samarasena","doi":"10.1016/j.cgh.2024.12.022","DOIUrl":"10.1016/j.cgh.2024.12.022","url":null,"abstract":"<p><strong>Background and aims: </strong>Endoscopic ultrasound-guided portosystemic pressure gradient measurement (EUS-PPG) is a novel technique to evaluate for portal hypertension (PH), a diagnosis that can prognosticate and guide therapy for patients. This study evaluated the safety and efficacy of EUS-PPG and correlation with clinical parameters and liver histology.</p><p><strong>Methods: </strong>We conducted a multicenter, retrospective study of patients undergoing EUS-PPG from January 2020 to December 2022 for suspected liver disease or PH. Linear regression was used to examine the relationship between EUS-PPG and clinical parameters of PH, and the chi-square test, Fisher's exact test, and Wilcoxon rank sum test described correlation with liver biopsy histology and noninvasive markers of fibrosis (Fibrosis-4, APRI [aspartate aminotransferase-to-platelet ratio index]). Logistic regression was performed to identify the strongest predictor of histologic cirrhosis.</p><p><strong>Results: </strong>Across 8 centers, 385 patients were enrolled and 373 had successful EUS-PPG (technical success 97%). Higher median PPGs were observed in patients with than without esophageal varices (11.6 mm Hg vs 4.1 mm Hg), portal hypertensive gastropathy (10.5 mm Hg vs 3.3 mm Hg), and thrombocytopenia (7.6 mm Hg vs 4.4 mm Hg) (P < .001). Individuals with PH and clinically significant PH (PPG >10) were 6.7 and 3.8 times more likely to have cirrhosis on histology, respectively. EUS-PPG was the best overall predictor of biopsy-proven cirrhosis (area under the curve 0.84) compared with Fibrosis-4 (0.72), and APRI (0.54). There were 2 minor adverse events related to PPG (postprocedural pain).</p><p><strong>Conclusions: </strong>EUS-PPG measurement was technically feasible and safe and demonstrated a strong correlation with clinical parameters of PH and liver histology. The strongest predictor of cirrhosis was EUS-PPG >5 mm Hg, which outperformed noninvasive markers of fibrosis.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074049","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.","authors":"Julia L Gauci, Anthony Whitfield, Michael J Bourke","doi":"10.1016/j.cgh.2024.12.012","DOIUrl":"10.1016/j.cgh.2024.12.012","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143074027","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}