Lancet Gastroenterology & Hepatology最新文献

{"title":"The Rome V criteria for the diagnosis of irritable bowel syndrome in secondary care: a diagnostic accuracy study.","authors":"Kyle Staller,Vivek C Goodory,Mais Khasawneh,Christopher J Black,Alexander C Ford","doi":"10.1016/s2468-1253(26)00118-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(26)00118-4","url":null,"abstract":"BACKGROUNDThe Rome V criteria for irritable bowel syndrome (IBS) were proposed in May, 2026. Their performance for the diagnosis of IBS in clinical practice is as yet unknown. We aimed to conduct a diagnostic accuracy study to examine this issue.METHODSThis diagnostic accuracy study was conducted in the specialist IBS clinic in Leeds Teaching Hospitals National Health Service Trust, Leeds, UK. Consecutive adults aged 16 years and older who were referred with suspected IBS between Sept 22, 2016, and June 18, 2024, provided complete symptom data. We applied standardised investigations (including full blood count, C-reactive protein, and coeliac serology), with assessors masked to symptom status. We assessed performance of the Rome V criteria, compared with the previous iterations, Rome IV and Rome III. The reference standard used to confirm IBS was the presence of lower abdominal pain or discomfort in association with altered stool form or frequency combined with no evidence of organic gastrointestinal disease after standardised investigations. Sensitivity, specificity, and positive and negative likelihood ratios were calculated for each of the diagnostic criteria, with 95% CIs.FINDINGSOf the 745 eligible patients recruited, 726 patients had complete Rome V symptom data (546 [75%] were female, 180 [25%] were male, and mean age was 36·9 years [SD 14·0]). 417 (57%) patients met Rome V criteria for IBS. The level of agreement between the Rome V and either the Rome III or Rome IV criteria was fair to moderate (κ=0·36-0·55). Of patients with complete Rome V symptom data, 590 had IBS according to the reference standard, of whom 390 met Rome V criteria for IBS. Sensitivity of the Rome V criteria was therefore 66·1% (95% CI 62·1-69·9) and specificity was 80·1% (72·4-86·5). Positive likelihood ratio for the Rome V criteria was 3·33 (95% CI 2·40-4·74) and negative likelihood ratio was 0·42 (0·37-0·49). The Rome III and Rome IV criteria for IBS performed differently, with sensitivities of 87·5% (95% CI 84·4-90·3) and 78·9% (75·4-82·1) and specificities of 75·0% (66·3-82·4) and 81·0% (73·4-87·2). Positive and negative likelihood ratios for the Rome III criteria were 3·50 (2·61-4·84) and 0·17 (0·13-0·21) and for the Rome IV criteria were 4·16 (2·98-5·95) and 0·26 (0·22-0·31).INTERPRETATIONThe Rome V criteria for IBS identified a different group of patients, with lower sensitivity than either Rome III or IV criteria in this single centre secondary care study. The clinical relevance of this is uncertain.FUNDINGNone.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"365 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2026-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148372543","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":"Effect of one or two cycles of dual immunotherapy with nivolumab and ipilimumab in patients with mismatch repair-deficient rectal cancer (RESET-R): interim results from a multicentre, single-arm, phase 2 trial.","authors":"Line Schmidt Tarpgaard, Laurids Østergaard Poulsen, Ismail Gögenur, Tobias Freyberg Justesen, Søren Rafael Rafaelsen, Nadia Øgaard, Christina Demuth, Claus Lindbjerg Andersen, Lise Ventzel, Pernille Øhlenschläger Larsen, Anne Ramlov, Ken Ljungmann, Michael Bødker Lauritzen, Laura Vittrup Diness, Jakob Lykke, Vinicius Araújo Barbosa de Lima, Søren Kjær, Søren Salomon, Per Vadgaard Andersen, Per Pfeiffer","doi":"10.1016/S2468-1253(26)00047-6","DOIUrl":"10.1016/S2468-1253(26)00047-6","url":null,"abstract":"<p><strong>Background: </strong>Mismatch repair-deficient (dMMR) tumours are highly sensitive to immune checkpoint blockade in the metastatic setting. Previous trials showed near-universal pathological responses after short-course dual immune checkpoint inhibition in patients with early-stage dMMR colon cancer, and high clinical complete response rates after 6 months of single-agent PD-1 blockade in patients with dMMR rectal cancer. We aimed to evaluate the activity and safety of a short duration of preoperative nivolumab and ipilimumab in patients with early or locally advanced dMMR rectal cancer.</p><p><strong>Methods: </strong>In the RESET-R trial, a multicentre, single-arm, phase 2 trial conducted in two hospitals in Denmark, we enrolled patients aged 18 years or older with histologically confirmed stage I-III dMMR rectal adenocarcinoma, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no previous systemic or local therapy for rectal cancer. Patients received one cycle of nivolumab (3 mg/kg intravenously on days 1 and 15) and ipilimumab (1 mg/kg intravenously on day 1). Patients with definite tumour regression but without clinical complete response at day 43 received a second cycle (nivolumab 3 mg/kg intravenously on days 50 and 65 and ipilimumab 1 mg/kg intravenously on day 50). The primary endpoint was the proportion of patients with a clinical complete response at day 93, defined as no visible or palpable tumour on rectal digital examination, endoscopy, and MRI. In patients with digital and endoscopic complete response, and with non-complete response on MRI, the absence of viable tumour cells in a representative biopsy was also classified as clinical complete response. Patients who had a clinical complete response were recommended to proceed with a watch-and-wait strategy without surgery. Analyses were done in the intention-to-treat population. The study was designed as a Simon two-stage trial, with an analysis for futility after enrolment of 19 participants. The study was to continue to enrol an additional 20 participants if six or more of the initial 19 participants had a clinical complete response, and the regimen would be deemed worthy of further investigation if 16 participants of the total 39 had a clinical complete response. An early interim analysis (and dissemination of the findings) was approved by the trial protocol committee when it became apparent that this measure of success had been met after enrolment of the first 16 participants. The trial is registered with EU Clinical Trials (2022-500646-14-00); the study is ongoing and continues to enrol patients.</p><p><strong>Findings: </strong>Between Feb 1, 2023, and Oct 28, 2025, 16 patients (nine [56%] male, seven [44%] female) were enrolled. Four (25%) patients had stage I tumours, two (13%) had stage II tumours, and ten (63%) had stage III tumours. All patients received at least one cycle of nivolumab and ipilimumab. By day 93, all 16 patients (100·0% [95%","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"570-578"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147823973","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":"Intestinal ultrasound to detect postoperative recurrence in patients with Crohn's disease: an international, multidisciplinary, RAND/UCLA appropriateness method study.","authors":"Christopher Ma, Siwar Albashir, Mariangela Allocca, Anthony de Buck van Overstraeten, Paulo G Kotze, Cathy Lu, Christian Maaser, Giovanni Maconi, Remo Panaccione, Miguel Regueiro, Jordi Rimola, Antonino Spinelli, Stuart A Taylor, Rune Wilkens, Willem Bemelman, Noa Krugliak Cleveland, Krisztina B Gecse, Susan Archer, Soushyant Kiarasi, Linda J Cornfield, Kerri L Novak","doi":"10.1016/S2468-1253(26)00082-8","DOIUrl":"10.1016/S2468-1253(26)00082-8","url":null,"abstract":"<p><strong>Background: </strong>Intestinal ultrasound is a non-invasive method increasingly used to diagnose and monitor disease activity in patients with inflammatory bowel disease; however, there is no consensus on the appropriate implementation of intestinal ultrasound to assess postoperative recurrence in Crohn's disease. We aimed to develop expert-based recommendations for standardising intestinal ultrasound use for the detection and evaluation of postoperative Crohn's disease recurrence.</p><p><strong>Methods: </strong>An international, multidisciplinary, modified RAND/University of California Los Angeles appropriateness method was used. Based on a systematic review and meta-analysis of the literature, expert opinion, and panellist feedback, a list of statements related to the use of intestinal ultrasound in this setting was generated. Panellists with expertise in Crohn's disease intestinal ultrasound, surgery, postoperative management, clinical trials, and outcome measures were invited. Panellists rated the appropriateness of each statement on a 9-point Likert scale in two rounds of voting, with statements classified as appropriate, inappropriate, or uncertain based on median panel rating and the presence of disagreement, then met in person to discuss the results and vote on the appropriate and inappropriate statements in a final round of ratification voting. Statements ratified by 75% or more of the panellists were incorporated into the final recommendations.</p><p><strong>Findings: </strong>The first online survey was open to the panellists from June 21, 2024, to Aug 6, 2024, and the second survey round was available between Nov 1 and Nov 25, 2024. The in-person ratification meeting was held on Feb 21, 2025. The panel comprised 16 experts (12 [75%] men and four [25%] women) from nine countries (Brazil, Canada, Denmark, Germany, Italy, the Netherlands, Spain, the UK, and the USA) with specialties in gastroenterology (n=10), colorectal surgery (n=4), and radiology (n=2). The overall response rate was 100% (all 16 panellists) for the first round of voting and 94% (15 of 16) for the second round of voting, with 12 (75%) of 16 panellists participating in ratification voting. The first survey contained 116 statements, with 88 (76%) rated as appropriate, two (2%) as inappropriate, and 26 (22%) as uncertain. Of the 122 statements in the second survey, 97 (80%) were rated appropriate, two (2%) were inappropriate, and 23 (19%) were uncertain. 79 statements were voted on during the ratification meeting and 67 (85%) were ratified. Recommended anatomical components for sonographic evaluation were the colonic segment immediately distal to the anastomosis, the neoterminal ileum, neoterminal ileal inlet, colonic and ileal blind side of the anastomosis, sonographically visible colonic segments, and the surrounding mesentery. Recommended parameters for assessment were bowel wall thickness, bowel wall stratification, bowel wall vascularity; mesenteric infl","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"602-615"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147984491","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 use of pharmacotherapies in non-cirrhotic metabolic dysfunction-associated steatohepatitis: a UK expert consensus.","authors":"Jeremy F Cobbold, Hamish Miller, Kate Hallsworth, Pinelopi Manousou, Thomas Marjot, Michael E D Allison, Quentin M Anstee, Matthew J Armstrong, Leah Avery, Vian Azzu, Paul N Brennan, Christopher D Byrne, Tessa M Cacciottolo, Lynsey Corless, Daniel Forton, Timothy Hardy, Vanessa Hebditch, Helen Jarvis, Wenhao Li, Dina Mansour, Stuart McPherson, Yensiew Miao, Joanne Morling, Ashis Mukhopadhya, Benjamin Mullish, Richard Parker, Imran Patanwala, Jay Patel, Michael Pavlides, Tina Reinson, Ian A Rowe, Francesca Saffioti, Faisal Shaikh, Ankur Srivastava, Nwe Ni Than, Emmanuel Tsochatzis, Edvard Volcek, Jeremy W Tomlinson, William Alazawi","doi":"10.1016/S2468-1253(26)00077-4","DOIUrl":"10.1016/S2468-1253(26)00077-4","url":null,"abstract":"<p><p>Metabolic dysfunction-associated steatohepatitis (MASH), a potentially progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD), increases risk of fibrosis progression, cirrhosis, and liver-related and cardiometabolic morbidity. The first licensed pharmacotherapies, resmetirom and semaglutide, mark a shift in management but practical guidance for real-world implementation is lacking. The British Association for the Study of the Liver and British Society of Gastroenterology MASLD special interest group developed consensus recommendations on patient selection, lifestyle management, and follow-up for MASLD-MASH-specific pharmacotherapy. 37 participants participated in a Delphi process where draft statements developed in working groups were anonymously rated, discussed, and refined. Consensus (≥80% agreement) was reached for 49 statements. The group agreed on the following general recommendation. Two-step non-invasive tests, including the Fibrosis-4 index and vibration-controlled transient elastography, are recommended to identify patients with presumed stage F2-F3 fibrosis (ie, at-risk MASH). Individuals with liver stiffness more than 10 kPa but without evidence of cirrhosis should be considered eligible for treatment. Lifestyle behaviour change intervention should accompany pharmacological treatment, delivered by suitably trained practitioners without delaying access to medication. Treatment discontinuation is advised with evidence of disease progression, cirrhosis development, or drug-induced liver injury. These recommendations offer pragmatic guidance to clinicians and consensus clinical opinion to regulatory bodies to support equitable and effective use of new MASLD-MASH therapies.</p>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"616-626"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147823970","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":"Correction to Lancet Gastroenterol Hepatol 2026; 11: 557-69.","authors":"","doi":"10.1016/S2468-1253(26)00161-5","DOIUrl":"10.1016/S2468-1253(26)00161-5","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"11 7","pages":"e9"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148220973","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 role of primary care in response to the global liver disease syndemic: a Lancet Gastroenterology & Hepatology Commission.","authors":"Helen Jarvis,Paul N Brennan,Teresa Casanovas,Kelly Casler,Monica Desai,Philip H Evans,John F Dillon,Ignazio Grattagliano,Kate Hallsworth,Vanessa Hebditch,Sema Mandal,Alisa E Pedrana,Jen-Kuei Peng,Andrew D Schreiner,Abdel-Aziz Shaheen,Maja Thiele,Patricia C Valery,Julia Verne,Shlomo Vinker,David Whiteley,Martin C S Wong,Shira Zelber-Sagi","doi":"10.1016/s2468-1253(26)00015-4","DOIUrl":"https://doi.org/10.1016/s2468-1253(26)00015-4","url":null,"abstract":"Liver disease causes substantial global morbidity and mortality, with a growing burden from steatotic liver disease driven by alcohol use and metabolic dysfunction, alongside persisting challenges from chronic viral hepatitis. Liver disease burden is unequal between and within countries, with high rates in people with low socioeconomic status and marginalised groups due to increased exposure to risk factors and compounded by reduced access to prevention, diagnosis, and treatment. Liver disease frequently coexists with multimorbidity-including diabetes, cancer, and mental illness-with bidirectional relationships that demand integrated, person-centred pathways of care. Primary care, as the cornerstone of first-contact, comprehensive health care, is uniquely positioned to deliver population-level prevention, early detection, and management of liver disease while reducing health disparities. However, despite increasing emphasis on prevention and long-term condition management globally, liver disease has received scarce attention within primary care policy, training, and system design. This Commission brings together multidisciplinary global expertise to review current evidence and provide recommendations to strengthen primary care-led liver health care. Central themes include reducing inequalities in liver care, defining a minimum package of primary care services, embedding liver health within non-communicable disease strategies, leveraging digital innovation, enhancing multidisciplinary collaboration, and advancing a coordinated research and implementation agenda focused on real-world care pathways and stigma reduction.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"1 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148365358","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 small interfering RNA imdusiran as single and multiple doses in healthy, randomised individuals and non-randomised individuals with chronic hepatitis B (AB-729-001): a phase 1a/b trial.","authors":"Man-Fung Yuen, Edward Gane, Jacinta A Holmes, Simone I Strasser, Apinya Leerapun, Wattana Sukeepaisarnjaroen, Pisit Tangkijvanich, Elina Berliba, Alina Jucov, Yoon Jun Kim, Young-Suk Lim, Emily P Thi, Timothy Eley, Kevin R Gray, Elina Medvedeva, Varun Sharma, Christine Espiritu, Sharie C Ganchua, Bhavna S Paratala, Christina Iott, Heather Sevinsky, Tiffany Fortney, Mark Anderson, Gavin A Cloherty, Michael J Sofia, Ganapati Reddy Pamulapati, Amy C H Lee, Gastón Picchio, Karen D Sims","doi":"10.1016/S2468-1253(26)00058-0","DOIUrl":"10.1016/S2468-1253(26)00058-0","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Functional cure of chronic hepatitis B requires a sustained loss of HBsAg and hepatitis B virus (HBV) DNA, which is unlikely with current therapies. We aimed to investigate the safety, antiviral activity, and anti-HBV immune responses of the N-acetylgalactosamine-conjugated, small interfering RNA imdusiran, a therapeutic strategy designed to reduce viral antigens on the path to achieving immune control.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;AB-729-001 was a phase 1a/b trial conducted at 11 centres and hospitals: three in Australia, one in New Zealand, three in Thailand, one in Hong Kong, two in South Korea, and one in Moldova. In part 1, which had a double-blinded, single ascending dose design consisting of four sequential dose groups, healthy individuals aged 18-45 years were randomly assigned (2:1), using fixed block randomisation (block number of two for 1:1 active:placebo sentinel dosing, followed by block number of four for 3:1 active:placebo for the next four participants), into three equal-sized cohorts and received subcutaneous imdusiran or placebo as a single dose of 60 mg, 180 mg, or 360 mg. Participants and investigators were masked to treatment assignment until part 1 was complete. Parts 2 and 3 were open-label and enrolled individuals aged 18-65 years with chronic hepatitis B, who were HBeAg-positive or HBeAg-negative and were taking or not taking nucleoside or nucleotide (nucleos[t]ide) analogue therapy (continued during the imdusiran treatment period), and who had HBsAg concentrations of at least 250 international units per mL, no clinically significant abnormalities on liver ultrasound, and an absence of cirrhosis. These participants received subcutaneous imdusiran as a single dose of 60 mg, 90 mg, or 180 mg (part 2) or as repeat doses of 60 mg or 90 mg every 4, 8, or 12 weeks for up to 48 weeks (part 3). The primary endpoint for all parts of the study was to evaluate the frequency and severity of treatment-emergent adverse events, discontinuations due to adverse events, and laboratory abnormalities following the administration of single doses to healthy participants (evaluated until day 29 after dosing) and of single and multiple doses of imdusiran to participants with chronic hepatitis B (evaluated until week 48 of follow-up and until month 36 of follow-up for participants who discontinued nucleos[t]ide analogue therapy after completing imdusiran treatment and meeting eligibility criteria). All individuals who received at least one dose of study drug comprised the safety population and were included in safety analyses. This study was registered with the Australia New Zealand Clinical Trials Registry-ACTRN12619000954123 (part 1), ACTRN12619001197123 (part 2), and ACTRN12620000295943 (part 3)-and is complete.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between July 16 and Aug 30, 2019, 18 individuals (18 [100%] male) were enrolled in part 1 and randomly assigned (12 [67%] to imdusiran and six [33%] to placebo). Betw","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"579-601"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148007642","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":"Breaking the cycle: from documenting data scarcity to enabling global IBD research.","authors":"Mohammed Nabil Quraishi, Badr Al-Bawardy, Rupa Banerjee, Maiara Brusco De Freitas, David Epstein, Tine Jess","doi":"10.1016/S2468-1253(26)00048-8","DOIUrl":"10.1016/S2468-1253(26)00048-8","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"11 7","pages":"546-549"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148220970","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":"Adjuvant chemoradiotherapy versus completion total mesorectal excision after local excision for early rectal cancer (TESAR): a multicentre, randomised, controlled, phase 3, non-inferiority trial.","authors":"Laura R Moolenaar, Mahsoem Ali, Theo J Aufenacker, Geerard L Beets, Robbert J I Bosker, Tineke E Buffart, Jacobus Wa Burger, Evelien Dekker, Quentin Denost, Pascal G Doornebosch, Peter van Duijvendijk, Hans F J Fabry, Elisabeth D Geijsen, Michael F Gerhards, Wilhelmina M U van Grevenstein, Brechtje A Grotenhuis, Christiaan Hoff, Jeroen W A Leijtens, Koen C M J Peeters, Apollo Pronk, George P van der Schelling, Colin Sietses, Anke B Smits, Boudewijn R Toorenvliet, Anthony W H van de Ven, Emiel G G Verdaasdonk, Ronald J C L M Vuylsteke, Henderik L van Westreenen, Johannes H W de Wilt, David D E Zimmerman, Marilyne M Lange, Nicole C T van Grieken, Barbara A J Bastiaansen, Roel Hompes, Corrie A Marijnen, Marcel G W Dijkgraaf, Leon M G Moons, Pieter J Tanis, Chris Cunningham, J B Tuynman","doi":"10.1016/S2468-1253(26)00109-3","DOIUrl":"10.1016/S2468-1253(26)00109-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Completion total mesorectal excision (cTME) after local excision of early rectal cancer is associated with substantial morbidity and impaired functional outcomes. This study aimed to assess the oncological outcomes of adjuvant chemoradiotherapy as an organ-preserving alternative in patients with high-risk pT1 and low-risk pT2 rectal cancer.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This multicentre, open-label, randomised, controlled, phase 3, non-inferiority trial was conducted at 25 hospitals across the Netherlands and France. Patients aged 18 years or older with locally excised high-risk pT1 and low-risk pT2 rectal cancer located below the sigmoid takeoff were randomly assigned (1:1), via an interactive web-response system, to adjuvant chemoradiotherapy (25 × 1·8 Gy limited to the mesorectum, with oral capecitabine 825 mg/m&lt;sup&gt;2&lt;/sup&gt; twice daily) or cTME through an interactive web-response system. Randomisation was done via minimisation with stratification for age (&lt;75 years vs ≥75 years), American Society of Anaesthesiologists (ASA) classification (ASA 1 vs ASA ≥2), type of local excision (surgical vs endoscopic), pathological tumour stage (high-risk pT1 vs low-risk pT2), and resection margin status (&lt;1 mm vs ≥1 mm). The primary endpoint was 3-year locoregional recurrence, with a prespecified non-inferiority margin of 7%. Secondary endpoints included unsalvageable locoregional recurrence, disease-free survival, overall survival, treatment-related morbidity within 30 days (assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events criteria for adjuvant chemoradiotherapy and the Clavien-Dindo classification and the Comprehensive Complication Index for cTME), stoma rate, and quality of life. All comparative analyses were conducted according to the intention-to-treat (ITT) and per-protocol principles. The trial is registered on ClinicalTrials.gov, NCT02371304. On Oct 1, 2024, the trial was converted to a patient-preference design due to loss of equipoise before reaching its target sample size of 302 patients. The current analysis includes patients randomly assigned until this transition. Enrolment is ongoing within the patient-preference design.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between Nov 1, 2015, and Sept 14, 2024, 202 patients were randomly assigned, of whom 197 were included in the ITT analysis (adjuvant chemoradiotherapy, n=101; cTME, n=96). Of these patients, 118 (59·9%) were male and 79 (40·1%) female; mean age was 64·7 years (SD 7·4), and mean BMI was 26·5 kg/m&lt;sup&gt;2&lt;/sup&gt; (SD 4·0). After a median follow-up of 50·0 months (IQR 27·0-62·0), five locoregional recurrences were reported: four in the adjuvant chemoradiotherapy group and one in the cTME group. Estimated 3-year locoregional recurrence rates were 5·0% (95% CI 1·6-11·3) after adjuvant chemoradiotherapy and 1·1% (0·0-5·5) after cTME. Adjuvant chemoradiotherapy did not meet the non-inferiority margin of 7% for 3-year locoregion","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"557-569"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148044820","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":"Management of colorectal cancer in older adults: an expert panel recommendation to guide daily clinical practice.","authors":"Gabor Liposits, Thierry André, Thomas Aparicio, Isacco Montroni, Julien Taieb, Claire Gallois, Eric Van Cutsem, Michel Ducreux, Per Pfeiffer, Sara Lonardi, Geerard L Beets, Karin Haustermans, Naureen Starling, Gerald W Prager, Gunnar Folprecht, Demetris Papamichael","doi":"10.1016/S2468-1253(26)00041-5","DOIUrl":"10.1016/S2468-1253(26)00041-5","url":null,"abstract":"<p><p>Colorectal cancer predominantly affects older adults (ie, those aged 70 years or older). Along with shifting demographic trends, the number of patients with colorectal cancer in this age group is estimated to sharply increase globally over the next few decades. During the past decade, new treatment modalities and systemic therapeutic options have been introduced through well conducted clinical trials that shaped and fundamentally redefined the treatment landscape. However, older adults with reduced physiological reserves, functional impairment, comorbidities, and geriatric syndromes are under-represented in such studies. Yet, for this population, growing evidence for geriatric assessment and management shows patient-centred benefits with the potential to further improve outcomes, parallel to the broadening armamentarium of medical innovations. The purpose of this Review is to summarise the evidence base of the current therapeutic landscape of colorectal cancer and guide management of older adults in daily clinical practice through pragmatic decision making.</p>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":" ","pages":"627-644"},"PeriodicalIF":39.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147977609","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}