Lancet Gastroenterology & Hepatology最新文献

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The promise of indocyanine green in colorectal surgery. 吲哚菁绿在结直肠手术中的应用前景。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-13 DOI: 10.1016/S2468-1253(24)00235-8
Zoe Garoufalia
{"title":"The promise of indocyanine green in colorectal surgery.","authors":"Zoe Garoufalia","doi":"10.1016/S2468-1253(24)00235-8","DOIUrl":"10.1016/S2468-1253(24)00235-8","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997032","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}
引用次数: 0
Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial. 在常规结肠镜检查实践中,使用 GI Genius 人工智能内镜检查模块辅助结肠镜检查与标准结肠镜检查进行息肉检测比较(COLO-DETECT):一项多中心、开放标签、平行臂、实用随机对照试验。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-14 DOI: 10.1016/S2468-1253(24)00161-4
Alexander Seager, Linda Sharp, Laura J Neilson, Andrew Brand, James S Hampton, Tom J W Lee, Rachel Evans, Luke Vale, John Whelpton, Nathania Bestwick, Colin J Rees
{"title":"Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial.","authors":"Alexander Seager, Linda Sharp, Laura J Neilson, Andrew Brand, James S Hampton, Tom J W Lee, Rachel Evans, Luke Vale, John Whelpton, Nathania Bestwick, Colin J Rees","doi":"10.1016/S2468-1253(24)00161-4","DOIUrl":"10.1016/S2468-1253(24)00161-4","url":null,"abstract":"<p><strong>Background: </strong>Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice.</p><p><strong>Methods: </strong>We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged ≥18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete.</p><p><strong>Findings: </strong>Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [55·7%] male, 900 [44·3%] female; mean age 62·4 years [SD 10·8]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (60·6%) participants were undergoing screening and 801 (39·4%) had symptomatic indications. Mean adenomas per procedure was 1·56 (SD 2·82; n=1001 participants with available data) in the CADe-assisted colonoscopy group versus 1·21 (1·91; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 0·36 (95% CI 0·14-0·57; adjusted incidence rate ratio 1·30 [95% CI 1·15-1·47], p<0·0001). Adenomas were detected in 555 (56·6%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (48·4%) of 986 in the standard colonoscopy group, representing a proportion d","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997031","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}
引用次数: 0
Metastatic pancreatic cancer: a new standardised dose-reduction regimen? 转移性胰腺癌:新的标准化剂量减少方案?
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-16 DOI: 10.1016/S2468-1253(24)00227-9
Paula Ghaneh, Daniel Palmer
{"title":"Metastatic pancreatic cancer: a new standardised dose-reduction regimen?","authors":"Paula Ghaneh, Daniel Palmer","doi":"10.1016/S2468-1253(24)00227-9","DOIUrl":"10.1016/S2468-1253(24)00227-9","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006004","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}
引用次数: 0
Breaking down barriers between liver, addiction, and mental health services for people with alcohol-related liver disease. 打破为酒精相关肝病患者提供的肝脏、成瘾和心理健康服务之间的障碍。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-06-25 DOI: 10.1016/S2468-1253(24)00189-4
Ashwin D Dhanda, Victoria Allgar, Neeraj Bhala, Lynne Callaghan, Joana Castro, Shilpa Chokshi, Amanda Clements, Colin Drummond, Ewan H Forrest, Lesle Manning, Richard Parker, Debbie L Shawcross, Jennifer Towey
{"title":"Breaking down barriers between liver, addiction, and mental health services for people with alcohol-related liver disease.","authors":"Ashwin D Dhanda, Victoria Allgar, Neeraj Bhala, Lynne Callaghan, Joana Castro, Shilpa Chokshi, Amanda Clements, Colin Drummond, Ewan H Forrest, Lesle Manning, Richard Parker, Debbie L Shawcross, Jennifer Towey","doi":"10.1016/S2468-1253(24)00189-4","DOIUrl":"10.1016/S2468-1253(24)00189-4","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141473047","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}
引用次数: 0
The need for affordable, pragmatic, investigator-led clinical trials of treatment strategies in inflammatory bowel disease. 需要对炎症性肠病的治疗策略进行负担得起的、务实的、由研究者主导的临床试验。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-07-31 DOI: 10.1016/S2468-1253(24)00225-5
Nurulamin M Noor, Shaji Sebastian, Miles Parkes, Tim Raine
{"title":"The need for affordable, pragmatic, investigator-led clinical trials of treatment strategies in inflammatory bowel disease.","authors":"Nurulamin M Noor, Shaji Sebastian, Miles Parkes, Tim Raine","doi":"10.1016/S2468-1253(24)00225-5","DOIUrl":"10.1016/S2468-1253(24)00225-5","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141879868","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}
引用次数: 0
Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. 吲哚菁绿近红外荧光肠道灌注评估以预防微创结直肠手术中的吻合口漏(AVOID):一项多中心、随机对照的 3 期试验。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-13 DOI: 10.1016/S2468-1253(24)00198-5
Robin A Faber, Ruben P J Meijer, Daphne H M Droogh, Jasmijn J Jongbloed, Okker D Bijlstra, Fran Boersma, Jeffrey P B M Braak, Elma Meershoek-Klein Kranenbarg, Hein Putter, Fabian A Holman, J Sven D Mieog, Peter A Neijenhuis, Esther van Staveren, Johanne G Bloemen, Jacobus W A Burger, Tjeerd S Aukema, Mark A M Brouwers, Andreas W K S Marinelli, Marinke Westerterp, Pascal G Doornebosch, Annelies van der Weijde, Koop Bosscha, Henricus J M Handgraaf, Esther C J Consten, Daan J Sikkenk, Jacobus Burggraaf, Stijn Keereweer, Joost R van der Vorst, Merlijn Hutteman, Koen C M J Peeters, Alexander L Vahrmeijer, Denise E Hilling
{"title":"Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial.","authors":"Robin A Faber, Ruben P J Meijer, Daphne H M Droogh, Jasmijn J Jongbloed, Okker D Bijlstra, Fran Boersma, Jeffrey P B M Braak, Elma Meershoek-Klein Kranenbarg, Hein Putter, Fabian A Holman, J Sven D Mieog, Peter A Neijenhuis, Esther van Staveren, Johanne G Bloemen, Jacobus W A Burger, Tjeerd S Aukema, Mark A M Brouwers, Andreas W K S Marinelli, Marinke Westerterp, Pascal G Doornebosch, Annelies van der Weijde, Koop Bosscha, Henricus J M Handgraaf, Esther C J Consten, Daan J Sikkenk, Jacobus Burggraaf, Stijn Keereweer, Joost R van der Vorst, Merlijn Hutteman, Koen C M J Peeters, Alexander L Vahrmeijer, Denise E Hilling","doi":"10.1016/S2468-1253(24)00198-5","DOIUrl":"10.1016/S2468-1253(24)00198-5","url":null,"abstract":"<p><strong>Background: </strong>Anastomotic leakage is a severe postoperative complication in colorectal surgery and compromised bowel perfusion is considered a major contributing factor. Conventional methods to assess bowel perfusion have a low predictive value for anastomotic leakage. We therefore aimed to evaluate the efficacy of real-time assessment with near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) in the prevention of anastomotic leakage.</p><p><strong>Methods: </strong>This multicentre, randomised, controlled, phase 3 trial was done in eight hospitals in the Netherlands. We included adults (aged >18 years) who were scheduled for laparoscopic or robotic colorectal surgery (with planned primary anastomosis) for benign and malignant diseases. Preoperatively, patients were randomly assigned (1:1) to fluorescence-guided bowel anastomosis (FGBA) or conventional bowel anastomosis (CBA) by variable block randomisation (block sizes 4, 6, and 8) and stratified by site. The operating surgeon and investigators analysing the data were not masked to group assignment. Patients were unmasked after the surgical procedure or after study end. In the FGBA group, surgeons marked anastomosis levels per conventional perfusion assessment and then administered 5 mg of ICG by 2 mL intravenous bolus. They assessed bowel perfusion using NIR fluorescence imaging and adjusted (or kept) transection lines accordingly. Only conventional methods for bowel perfusion assessment were used in the CBA group. The primary outcome was the difference in the rate of clinically relevant anastomotic leakage (ie, requiring active therapeutic intervention but manageable without reoperation [grade B] or requiring reoperation [grade C], per the International Study Group of Rectal Cancer) between the FGBA group and the CBA group within 90 days post-surgery. The primary outcome and safety were assessed in the intention-to-treat population. This study was registered with ToetsingOnline.nl (NL7502) and ClinicalTrials.gov (NCT04712032) and is complete.</p><p><strong>Findings: </strong>Between July 2, 2020, and Feb 21, 2023, 982 patients were enrolled, of whom 490 were assigned to FGBA and 492 were assigned to CBA. After excluding 51 patients, the intention-to-treat population comprised 931 (463 assigned FGBA and 468 assigned CBA). Patients had a median age of 68·0 years (IQR 59·0-75·0) and 485 (52%) were male and 446 (48%) were female. Ethnicity data were not available. The overall 90-day rate of clinically relevant anastomotic leakage was not significantly different between the FGBA group (32 [7%] of 463 patients) and the CBA group (42 [9%] of 468 patients; relative risk 0·77 [95% CI 0·50-1·20]; p=0·24). No adverse events related to ICG use were observed. 313 serious adverse events in 229 (25%) patients were at 90-day follow-up (159 serious adverse events in 113 [24%] patients in the FGBA group and 154 serious adverse events in 116 [25%] patients in the CBA group). 18 ","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141997030","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}
引用次数: 0
Gastrointestinal effects of GLP-1 receptor agonists: mechanisms, management, and future directions. GLP-1 受体激动剂的胃肠道效应:机制、管理和未来方向。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-01 DOI: 10.1016/S2468-1253(24)00188-2
Ryan J Jalleh, Chris K Rayner, Trygve Hausken, Karen L Jones, Michael Camilleri, Michael Horowitz
{"title":"Gastrointestinal effects of GLP-1 receptor agonists: mechanisms, management, and future directions.","authors":"Ryan J Jalleh, Chris K Rayner, Trygve Hausken, Karen L Jones, Michael Camilleri, Michael Horowitz","doi":"10.1016/S2468-1253(24)00188-2","DOIUrl":"10.1016/S2468-1253(24)00188-2","url":null,"abstract":"<p><p>The availability of glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) such as liraglutide and semaglutide, and a GLP-1 and glucose dependent insulinotropic polypeptide coagonist (tirzepatide) represents a paradigm shift in the management of both type 2 diabetes and obesity. There is now considerable attention, including in the public media, on the effect of both long-acting and short-acting GLP-1RAs to delay gastric emptying. Although slowed gastric emptying is integral to reducing post-prandial blood glucose responses in type 2 diabetes, marked slowing of gastric emptying might also increase the propensity for longer intragastric retention of food, with a consequent increased risk of aspiration at the time of surgery or upper gastrointestinal endoscopy. This Personal View summarises current knowledge of the effects of GLP-1 and GLP-1RAs on gastrointestinal physiology, particularly gastric emptying, and discusses the implications for the development of sound pre-operative or pre-procedural guidelines. The development of pre-procedural guidelines is currently compromised by the poor evidence base, particularly in relation to the effect of long-acting GLP-1RAs on gastric emptying. We suggest pre-procedural management pathways for individuals on GLP-1RA-based therapy and discuss priorities for future research.</p>","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141891119","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}
引用次数: 0
Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial. 转移性胰腺癌诱导治疗(ALPACA)后吉西他滨加纳布-紫杉醇和吉西他滨单药交替治疗与吉西他滨加纳布-紫杉醇连续治疗:一项多中心、随机、开放标签的 2 期试验。
IF 30.9 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-10-01 Epub Date: 2024-08-16 DOI: 10.1016/S2468-1253(24)00197-3
Klara Dorman, Stefan Boeck, Karel Caca, Maximilian Reichert, Thomas J Ettrich, Helmut Oettle, Oliver Waidmann, Dominik P Modest, Lothar Müller, Patrick Michl, Stephan Kanzler, Daniel Pink, Anke Reinacher-Schick, Michael Geißler, Henning Pelz, Volker Kunzmann, Swantje Held, Thomas Schichtl, Volker Heinemann, Frank Kullmann
{"title":"Alternating gemcitabine plus nab-paclitaxel and gemcitabine alone versus continuous gemcitabine plus nab-paclitaxel after induction treatment of metastatic pancreatic cancer (ALPACA): a multicentre, randomised, open-label, phase 2 trial.","authors":"Klara Dorman, Stefan Boeck, Karel Caca, Maximilian Reichert, Thomas J Ettrich, Helmut Oettle, Oliver Waidmann, Dominik P Modest, Lothar Müller, Patrick Michl, Stephan Kanzler, Daniel Pink, Anke Reinacher-Schick, Michael Geißler, Henning Pelz, Volker Kunzmann, Swantje Held, Thomas Schichtl, Volker Heinemann, Frank Kullmann","doi":"10.1016/S2468-1253(24)00197-3","DOIUrl":"10.1016/S2468-1253(24)00197-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;A standardised dose-reduction strategy has not been established for the widely used gemcitabine plus nab-paclitaxel regimen in patients with metastatic pancreatic ductal adenocarcinoma. We aimed to investigate the efficacy and tolerability of alternating treatment cycles of nab-paclitaxel-gemcitabine combination therapy and gemcitabine alone versus continuous treatment with the nab-paclitaxel-gemcitabine combination.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;ALPACA was a randomised, open-label, phase 2 trial conducted at 29 study centres across Germany. Patients aged 18 years or older with a histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma who had not been previously treated for advanced disease were enrolled. After an induction phase with three cycles of nab-paclitaxel-gemcitabine combination therapy (nab-paclitaxel 125 mg/m&lt;sup&gt;2&lt;/sup&gt; and gemcitabine 1000 mg/m&lt;sup&gt;2&lt;/sup&gt; administered intravenously on days 1, 8, and 15 of each 28-day cycle), patients were randomly assigned (1:1) by stratified permuted block randomisation either to continue treatment with standard nab-paclitaxel-gemcitabine or to receive alternating cycles of nab-paclitaxel-gemcitabine and gemcitabine alone. Patients and investigators were not masked to treatment allocation. Randomisation was done centrally by the study statistician using a computer-generated randomisation list, and was stratified by Karnofsky Performance Status and presence of liver metastases. The primary endpoint was the derivation of an unbiased point estimate and an associated confidence interval with a confidence coefficient of 80% for the hazard ratio (HR) for overall survival after randomisation, without testing a specific hypothesis, analysed by intention to treat in all patients who started randomised treatment. Safety was analysed according to treatment received. This trial is registered with ClinicalTrials.gov, NCT02564146, and is completed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Between May 27, 2016, and May 27, 2021, 325 patients were enrolled. Following three cycles of induction treatment, 174 patients were randomly assigned: 85 to continue receiving standard nab-paclitaxel-gemcitabine, of whom 79 started treatment, and 89 to the alternating treatment schedule, of whom 88 started treatment. Of the 167 patients who started randomised treatment, 88 (53%) were female and 79 (47%) were male. Median overall survival after randomisation was 10·4 months (80% CI 9·2-12·0) in the group that received standard treatment and 10·5 months (10·2-11·1) in the group that received alternating treatment (HR 0·90, 80% CI 0·72-1·13; p=0·56). The most common adverse events of any grade were peripheral neuropathy (59 [74%] of 80 patients in the continuous treatment group vs 53 [62%] of 85 patients in the alternating treatment group) and fatigue (43 [54%] vs 44 [52%]). Treatment-emergent serious adverse events after randomisation occurred in 40 (50%) pati","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":30.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006003","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}
引用次数: 0
Spleen stiffness measurement by vibration-controlled transient elastography at 100 Hz for non-invasive predicted diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a modelling study. 通过 100 Hz 振动控制瞬态弹性成像技术测量脾脏硬度,用于无创预测诊断代偿期晚期慢性肝病患者具有临床意义的门静脉高压症:一项模型研究。
IF 35.7 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-09-23 DOI: 10.1016/s2468-1253(24)00234-6
Mathias Jachs,Aitor Odriozola,Fanny Turon,Lucile Moga,Luis Téllez,Petra Fischer,Dario Saltini,Wilhelmus J Kwanten,Maria Grasso,Elba Llop,Yuly P Mendoza,Angelo Armandi,Julia Thalhammer,Carlos Pardo,Antonio Colecchia,Federico Ravaioli,Benjamin Maasoumy,Wim Laleman,José Presa,Jörn M Schattenberg,Annalisa Berzigotti,José L Calleja,Vincenza Calvaruso,Sven Francque,Filippo Schepis,Bogdan Procopet,Agustín Albillos,Pierre-Emmanuel Rautou,Juan C García-Pagán,Ángela Puente,José I Fortea,Thomas Reiberger,Mattias Mandorfer,,
{"title":"Spleen stiffness measurement by vibration-controlled transient elastography at 100 Hz for non-invasive predicted diagnosis of clinically significant portal hypertension in patients with compensated advanced chronic liver disease: a modelling study.","authors":"Mathias Jachs,Aitor Odriozola,Fanny Turon,Lucile Moga,Luis Téllez,Petra Fischer,Dario Saltini,Wilhelmus J Kwanten,Maria Grasso,Elba Llop,Yuly P Mendoza,Angelo Armandi,Julia Thalhammer,Carlos Pardo,Antonio Colecchia,Federico Ravaioli,Benjamin Maasoumy,Wim Laleman,José Presa,Jörn M Schattenberg,Annalisa Berzigotti,José L Calleja,Vincenza Calvaruso,Sven Francque,Filippo Schepis,Bogdan Procopet,Agustín Albillos,Pierre-Emmanuel Rautou,Juan C García-Pagán,Ángela Puente,José I Fortea,Thomas Reiberger,Mattias Mandorfer,,","doi":"10.1016/s2468-1253(24)00234-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00234-6","url":null,"abstract":"BACKGROUNDIn patients with compensated advanced chronic liver disease (cACLD), risk of clinically significant portal hypertension (CSPH) can be estimated by applying non-invasive tests such as liver stiffness measurement (LSM), platelet count, and, in some cases, BMI. We aimed to assess the diagnostic utility of spleen stiffness measurement (SSM) at 100 Hz as a standalone non-invasive test for CSPH and to evaluate its incremental value compared with the ANTICIPATE±NASH model in patients with cACLD.METHODSFor this modelling study, patients were recruited from 16 expert centres in Europe. Patients who underwent characterisation by hepatic venous pressure gradient (HVPG) and non-invasive tests (ie, LSM, platelet count, and SSM at 100 Hz) at one of the participating centres between Jan 1, 2020, and Dec 31, 2023, were considered for inclusion. Only patients aged 18 years or older with Child-Pugh class A cACLD, shown by LSM 10 kPa or more or F3 or F4 fibrosis on liver histology, were included. The overall cohort was split into the derivation cohort (patients recruited between Jan 1, 2020, and Dec 31, 2022) and the temporal validation cohort (patients recruited between Jan 1, 2023, and Dec 31, 2023). The ANTICIPATE±NASH model was applied to assess individual CSPH probability and SSM was investigated as a standalone non-invasive test for CPSH; in combination with platelet count and BMI; and in a full model of SSM, LSM, platelet count, and BMI (ie, the Non-Invasive CSPH Estimated Risk [NICER] model). All models were binary logistic regression models. The primary outcome was CSPH. We evaluated the discriminative utility of the models by calculating the area under the receiver operating characteristics curve (AUC) and creating calibration plots and calibration of intercept, slope, and integrated calibration index.FINDINGS407 patients with cACLD were included, 202 (50%) in the derivation cohort and 205 (50%) in the validation cohort. Median age was 60·0 years (IQR 55·0-66·8); 275 (68%) of 407 patients were male and 132 (32%) were female. 164 (40%) of 407 patients had metabolic dysfunction-associated steatotic liver disease (MASLD), 133 (33%) had MASLD with increased alcohol intake or alcohol-related liver disease, 75 (18%) had viral hepatitis (61 [81%] of whom had sustained virologic response of hepatitis C virus or suppression of hepatitis B virus DNA), and 35 (9%) had other chronic liver diseases. 241 (59%) patients had CSPH. Median SSM was 45·0 kPa (32·1-65·4) and LSM was 21·4 kPa (14·1-31·6). SSM and LSM had similar AUCs for prediction of CSPH in the derivation cohort (0·779 [95% CI 0·717-0·842] vs 0·781 [0·718-0·844]; p=0·97) and in the validation cohort (0·830 [0·772-0·887] vs 0·804 [0·743-0·864]; p=0·50). The SSM-based model comprising platelet count and BMI had a similar AUC as the ANTICIPATE±NASH model in both the derivation cohort (0·849 [0·794-0·903] vs 0·849 [0·794-0·903]; p=0·999) and in the validation cohort (0·873 [0·819-0·922] vs 0·863 [0·810","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328669","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}
引用次数: 0
Spleen stiffness in portal hypertension algorithms: the next advance. 门静脉高压算法中的脾脏硬度:下一个进步。
IF 35.7 1区 医学
Lancet Gastroenterology & Hepatology Pub Date : 2024-09-23 DOI: 10.1016/s2468-1253(24)00249-8
Cristina Rigamonti
{"title":"Spleen stiffness in portal hypertension algorithms: the next advance.","authors":"Cristina Rigamonti","doi":"10.1016/s2468-1253(24)00249-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00249-8","url":null,"abstract":"","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":null,"pages":null},"PeriodicalIF":35.7,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328758","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}
引用次数: 0
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