Lancet Gastroenterology & Hepatology最新文献

{"title":"Lessons learned from the BOSS trial: new directions in Barrett's oesophagus","authors":"Rebecca C Fitzgerald, Peter Sasieni","doi":"10.1016/s2468-1253(25)00160-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00160-8","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"14 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144305212","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":"Pre-emptive TIPS for gastric variceal bleeding: an important first step but a long way to go","authors":"Michael Praktiknjo, Jonel Trebicka","doi":"10.1016/s2468-1253(25)00162-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00162-1","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"6 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144278713","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":"Primary biliary cholangitis and the narrowing gap towards optimal disease control","authors":"Guilherme Grossi Lopes Cançado, Ana Lleo, Cynthia Levy, Michael Trauner, Gideon M Hirschfield","doi":"10.1016/s2468-1253(25)00025-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00025-1","url":null,"abstract":"Although infrequent, primary biliary cholangitis is not indolent and remains a burdensome chronic autoimmune biliary disease. Progressive biliary injury and cholestasis results in complications of biliary cirrhosis, with reduced quality and quantity of life. Treatment advances beyond ursodeoxycholic acid and liver transplantation are notable, as efforts grow to prevent end-stage liver disease. Early identification of individuals at greatest risk for progression, in advance of cirrhosis, enhances treatment benefit. Intuitive care focuses on the best outcomes, such as biochemical control of disease (eg, normal alkaline phosphatase and bilirubin) and mitigation of symptoms (eg, pruritus). A multi-faceted approach to targeted therapeutic options is emerging to apply therapy beyond bile acid pool modification (ursodeoxycholic acid), including farnesoid X receptor agonism, peroxisome proliferator-activated receptor agonism, and ileal bile acid transporter inhibition. Obstacles to evaluating treatments include a prolonged clinical course, the difficulty in conducting long-term, placebo-controlled studies, and challenges in measuring quality of life effects. Generating robust, contemporaneous real-world evidence is therefore important in the primary biliary cholangitis space.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"25 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144278712","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":"Pre-emptive TIPS for gastric variceal bleeding in patients with cirrhosis (GAVAPROSEC): an open-label randomised clinical trial","authors":"Jean-Paul Cervoni, Delphine Weil, Maxime Desmarets, Adrien Lannes, Louis D'Alteroche, Charlotte Bouzbib, Hélène Larrue, Elise Lemaitre, Stéphanie Faure, Mariane Latournerie, Caroline Jézéquel, Claire Billioud, Nicolas Carbonell, Faouzi Saliba, Florence Tanné, Jean-Baptiste Hiriart, Isabelle Olivier-Hourmand, Eric Nguyen Khac, Isabelle Archambeaud, Marie-Noelle Hilleret, Teresa Antonini","doi":"10.1016/s2468-1253(25)00156-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00156-6","url":null,"abstract":"<h3>Background</h3>In patients with cirrhosis, variceal glue obliteration is recommended for the treatment of acute fundal variceal bleeding, and for the prevention of rebleeding in combination with non-selective β blockers (NSBB). We evaluated the efficacy of pre-emptive transjugular intrahepatic portosystemic shunt (p-TIPS) in this setting.<h3>Methods</h3>This open-label randomised trial was conducted at 17 tertiary centres in France. Patients with cirrhosis and acute fundal variceal bleeding (excluding type 1 gastro-oesophageal varices), who achieved initial haemostasis with endoscopic glue injection and vasoactive therapy, and remained stable for at least 12 h, were randomly assigned to receive either a covered p-TIPS within 72 h or to continue with on-demand glue obliteration sessions combined with NSBB. Randomisation was centralised, stratified by centre, and performed in blocks of four (1:1 ratio). The primary composite endpoint was all-cause mortality or clinically significant rebleeding within 1 year. Analyses were conducted in the modified intention-to-treat (mITT) population. This completed study was registered on <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span> (<span><span>NCT03705078</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>).<h3>Findings</h3>Between Jan 3, 2019, and Feb 25, 2023, 292 patients were screened, of whom 105 were enrolled and randomly assigned. After excluding two patients who were randomly assigned by error and two who withdrew consent, 101 patients were included in the mITT population (mean age 58·2 years [SD 9·7], 81 [80%] male, 91 [90%] alcohol-related cirrhosis, mean MELD score 14·3 [SD 5·0]). Of these 101 patients, 47 were allocated to p-TIPS and 54 to glue obliteration and NSBB. The 1-year probability of being free from death or rebleeding was 77% (95% CI 62–87) in the p-TIPS group versus 37% (24–50) in the glue obliteration and NSBB group (hazard ratio 0·25 [95% CI 0·12–0·51]; p&lt;0·0001). Rescue TIPS was required in 20 (37%) patients in the control group. Glue migration was reported in eight patients (three [6%] in the p-TIPS group and five [9%] in the control group). One case of cardiac decompensation occurred in the p-TIPS group. The 1-year cumulative incidence of hepatic encephalopathy was similar between groups (35% [95% CI 21–49] <em>vs</em> 32% [19–45]).<h3>Interpretation</h3>In patients with cirrhosis and acute bleeding from fundal varices, p-TIPS significantly reduced the risk of rebleeding or death at 1 year and should be considered as first-line therapy.<h3>Funding</h3>French Ministry of Health.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"12 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144278715","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":"Faecal incontinence core outcome set: an international Delphi consensus exercise among patients, health-care professionals, and researchers","authors":"Sadé L Assmann, Daniel Keszthelyi, Merel L Kimman, Stéphanie O Breukink","doi":"10.1016/s2468-1253(25)00013-5","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00013-5","url":null,"abstract":"Faecal incontinence is a debilitating anorectal disorder that can severely affect a person's quality of life. The variability in reported outcomes in studies on treatments for faecal incontinence complicates the synthesis of evidence, thereby weakening treatment recommendations. Furthermore, the emphasis on clinical outcomes often neglects outcomes that are crucial to patients' daily lives. Incorporating diverse stakeholder perspectives, we aimed to develop a core outcome set (COS)—a minimum set of outcomes that should be measured in future studies evaluating the efficacy of a treatment in adults with faecal incontinence. Following guidelines from the COMET initiative, this study proceeded through three steps: identifying outcomes via patient interviews and a systematic literature review; ranking and refining outcomes through two rounds of Delphi surveys involving patients, health-care professionals, and researchers; and finalising the COS through a consensus meeting with relevant stakeholders. Round 1 of the Delphi survey included 109 participants (73 health-care professionals and researchers and 36 patients) and round 2 involved 74 participants (54 and 20, respectively). In both rounds, participants ranked the importance of potential outcomes on a 9-point Likert scale. Of the 58 outcomes that entered round 1 and the three that were later added, 27 outcomes were voted out and the remaining 34 were discussed during a consensus meeting to finalise the COS. The final COS encompasses 13 outcomes: seven quality of life-related outcomes (quality of life, influence on daily activities, social functioning, treatment satisfaction, enjoyment in life, embarrassment, and peace of mind) and six clinical outcomes (severity of faecal incontinence, number of faecal incontinence episodes, urgency, stool consistency, adverse events, and adherence to therapy). This study establishes what outcomes should be included in a COS for use in faecal incontinence research, but future research is needed to identify the appropriate measurement instruments for each outcome and to establish appropriate timing for their assessment, which will further refine outcome definitions before this COS can be implemented. Once these aspects are clarified, the COS can be adopted into faecal incontinence research, which we hope will ultimately improve clinical care.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"12 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144268981","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":"Development and validation of a novel Endoscopic ulcer Activity Score for Evaluation of Crohn's Disease (EASE-CD) using data from two randomised controlled trials","authors":"Christopher Ma, Reena Khanna, Bryan R Maguire, Guangyong Zou, Brian Bressler, Pieter Hindryckx, Mahmoud Mosli, Miles P Sparrow, Ailsa L Hart, Rupert W Leong, David T Rubin, Julie Rémillard, Lisa M Shackelton, Geert R D'Haens, Silvio Danese, Laurent Peyrin-Biroulet, Bruce E Sands, Remo Panaccione, Brian G Feagan, Vipul Jairath","doi":"10.1016/s2468-1253(25)00093-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00093-7","url":null,"abstract":"<h3>Background</h3>Endoscopy is essential for measuring luminal disease activity in Crohn's disease. Existing indices for evaluating endoscopic Crohn's disease activity are only modestly correlated with clinical disease activity, contain items with ambiguous definitions and poor interobserver reliability, and do not have validated thresholds for defining clinically relevant changes. To address these issues, we conducted a multiphase study to develop and validate a novel endoscopic index for Crohn's disease.<h3>Methods</h3>Paired baseline and post-induction ileocolonoscopy videos from a phase 3b adalimumab trial (<span><span>NCT00348283</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) and phase 2 risankizumab trial (<span><span>NCT02031276</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>) were assessed by multiple central readers using candidate endoscopic items with face validity derived using modified RAND/UCLA appropriateness methods. The four readers were masked to all clinical information, including treatment assignment and patient symptom scores. A total of 112 and 99 paired ileocolonoscopy videos with treatment assignment were available from the adalimumab trial and risankizumab trial, respectively; after the four readers assessed the 112 videos, two readers then reassessed 44 post-treatment videos to assess inter-rater reliability in index development. Items with acceptable inter-rater reliability (with an intraclass correlation coefficient [ICC] of ≥0·41) and responsiveness (win probability [WinP], the probability that a patient receiving active treatment has a better endoscopy score than a patient receiving placebo, of ≥0·56) were included as covariables in regression for model building with internal validation with bootstrapping. External validation was conducted using the paired videos from the risankizumab trial.<h3>Findings</h3>Ten endoscopic items met ICC and WinP thresholds and were considered for novel index development. They included items from the SES-CD (presence and size of ulcers, extent of ulcerated surface, and extent of affected surface) and CDEIS (percentage of surface involved by Crohn's disease, percentage of ulcerated surface, deep ulceration, and superficial ulceration) and exploratory items (presence of Crohn's disease-related lesions, Crohn's disease-related lesion severity, and Crohn's disease-related lesion involvement). The final model, Endoscopic ulcer Activity Score for Evaluating CD (EASE-CD), included the presence and size of ulcerations measured on an ordinal scale of 0 (none), 1 (ulcers &lt;5 mm), 2 (ulcers between 5 mm and 20 mm), and 3 (ulcers &gt;20 mm); the presence or absence of de","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"2 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144252536","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 new endoscopic paradigm: evaluating the EASE-CD score for Crohn's disease","authors":"Yoram Bouhnik, Jean Yves Mary","doi":"10.1016/s2468-1253(25)00127-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00127-x","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"26 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144252535","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":"Efimosfermin alfa (BOS-580), a long-acting FGF21 analogue, in participants with phenotypic metabolic dysfunction-associated steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2a trial","authors":"Rohit Loomba, Kris V Kowdley, Jose Rodriguez, Nomita J Kim, Alina Maria Alvarez, Linda Morrow, Brenda Jeglinski, Alicia Clawson, Swapan Chowdhury, Gerard Bain, Tatjana Odrljin","doi":"10.1016/s2468-1253(25)00067-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00067-6","url":null,"abstract":"&lt;h3&gt;Background&lt;/h3&gt;Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive disease characterised by steatosis, inflammation, and liver fibrosis. Efimosfermin alfa (efimosfermin, formerly BOS-580) is a long-acting, engineered variant of FGF21 designed to have a prolonged half-life. We aimed to assess the safety and tolerability of multiple efimosfermin doses and dosing regimens compared with placebo and to evaluate exploratory biomarkers of efficacy in participants with phenotypic MASH.&lt;h3&gt;Methods&lt;/h3&gt;This multicentre, randomised, double-blind, placebo-controlled, phase 2a trial was conducted at 12 centres in the USA. Individuals with phenotypic MASH, aged 18–75 years and with a BMI of 30–45 kg/m&lt;sup&gt;2&lt;/sup&gt;, were eligible for the study. Participants were randomly assigned, using a centralised interactive randomisation system with no stratification factors, to one of five dosing cohorts: efimosfermin 75 mg once every 4 weeks, 75 mg once every 2 weeks, 150 mg once every 4 weeks, 150 mg once every 2 weeks, or 300 mg once every 4 weeks, for a 12-week treatment period. Participants were assigned 1:1:1:1 to all cohorts except efimosfermin 150 mg once every 4 weeks, which was initiated after assignment to the other cohorts was complete. Within each cohort, participants were randomly assigned 4:1 to receive efimosfermin or placebo, via subcutaneous injection, in fixed blocks of size five. Investigators and participants were masked to group assignment and treatment allocation. The primary endpoint was safety and tolerability and was assessed throughout the 12-week treatment period and at the follow-up visit 4 weeks after the final dose in the full analysis set, defined as enrolled participants who received at least one dose of study medication. Part A (reported here) of this phase 2 study is complete, while other parts of the phase 2 study are ongoing. This trial is registered with &lt;span&gt;&lt;span&gt;ClinicalTrials.gov&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt; (&lt;span&gt;&lt;span&gt;NCT04880031&lt;/span&gt;&lt;svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"&gt;&lt;path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"&gt;&lt;/path&gt;&lt;/svg&gt;&lt;/span&gt;).&lt;h3&gt;Findings&lt;/h3&gt;Between Aug 27, 2021, and July 22, 2022, 360 individuals were screened, of whom 102 were eligible and were randomly assigned to receive placebo (n=37) or efimosfermin 75 mg every 4 weeks (n=8), 75 mg every 2 weeks (n=14), 150 mg every 4 weeks (n=15), 150 mg every 2 weeks (n=15), or 300 mg every 4 weeks (n=13), for a total of 12 weeks. 45 (44%) of the 102 participants were female and 57 (56%) were male, with a mean age of 53 years (SD 11) and mean BMI of 36·5 kg/m&lt;sup&gt;2&lt;/sup&gt; (SD 4·1). Of 65 participants treated with efimosfermin, 43 (66%) had treatment-emergent adverse eve","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"18 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228920","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":"GLP-1 receptor agonists in alcohol use disorder and alcohol-associated liver disease","authors":"Ashwani K Singal, Lorenzo Leggio","doi":"10.1016/s2468-1253(25)00134-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00134-7","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"16 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144218941","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":"Refining clinical success metrics in EUS-guided gastroenterostomy","authors":"Giuseppe Vanella, Michiel Bronswijk, Roy L J van Wanrooij, Schalk van der Merwe, Paolo Giorgio Arcidiacono","doi":"10.1016/s2468-1253(23)00448-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(23)00448-x","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"62 1","pages":"615-616"},"PeriodicalIF":35.7,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144218965","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}