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Study protocol for a Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in Acute Variceal Bleeding (REACT-AVB trial). 急性静脉曲张出血经颈静脉腔内支架分流术随机对照试验(REACT-AVB 试验)研究方案。
IF 3.1 Q2 Medicine Pub Date : 2024-03-22 DOI: 10.1136/bmjgast-2023-001314
Dhiraj Tripathi, David Patch, Homoyon Mehrzad, Dominic Yu, Richard J Aspinall, Matthew J Armstrong, Adrian Stanley, Hamish Ireland, Simon Travis, Peter Hayes, Mandy Lomax, Nicholas Roslund, Emily Lam, Gemma Slinn, Sue Jowett, Catherine Moakes, Alisha Maher, Elizabeth Brettell, Sukhwant Sehmi

Introduction: In liver cirrhosis, acute variceal bleeding (AVB) is associated with a 1-year mortality rate of up to 40%. Data on early or pre-emptive transjugular intrahepatic portosystemic stent-shunt (TIPSS) in AVB is inconclusive and may not reflect current management strategies. Randomised controlled trial of EArly transjugular intrahepatiC porTosystemic stent-shunt in AVB (REACT-AVB) aims to investigate the clinical and cost-effectiveness of early TIPSS in patients with cirrhosis and AVB after initial bleeding control.

Methods and analysis: REACT-AVB is a multicentre, randomised controlled, open-label, superiority, two-arm, parallel-group trial with an internal pilot. The two interventions allocated randomly 1:1 are early TIPSS within 4 days of diagnostic endoscopy or secondary prophylaxis with endoscopic therapy in combination with non-selective beta blockers. Patients aged ≥18 years with cirrhosis and Child-Pugh Score 7-13 presenting with AVB with endoscopic haemostasis are eligible for inclusion. The primary outcome is transplant-free survival at 1 year post randomisation. Secondary endpoints include transplant-free survival at 6 weeks, rebleeding, serious adverse events, other complications of cirrhosis, Child-Pugh and Model For End-Stage Liver Disease (MELD) scores at 6 and 12 months, health-related quality of life, use of healthcare resources, cost-effectiveness and use of cross-over therapies. The sample size is 294 patients over a 4-year recruitment period, across 30 hospitals in the UK.

Ethics and dissemination: Research ethics committee of National Health Service has approved REACT-AVB (reference number: 23/WM/0085). The results will be submitted for publication in a peer-reviewed journal. A lay summary will also be emailed or posted to participants before publication.

Trial registration number: ISRCTN85274829; protocol version 3.0, 1 July 2023.

导言:肝硬化患者急性静脉曲张出血(AVB)的 1 年死亡率高达 40%。有关 AVB 早期或先期经颈静脉肝内门体支架分流术(TIPSS)的数据尚无定论,可能无法反映当前的管理策略。AVB 早期经颈静脉肝内门体支架分流术随机对照试验(REACT-AVB)旨在研究肝硬化和 AVB 患者在初步控制出血后进行早期 TIPSS 的临床和成本效益:REACT-AVB 是一项多中心、随机对照、开放标签、优势、双臂、平行组试验,并有一个内部试点。两种干预措施按 1:1 随机分配,即在诊断性内镜检查后 4 天内进行早期 TIPSS 或使用内镜治疗联合非选择性β受体阻滞剂进行二级预防。年龄≥18 岁、患有肝硬化、Child-Pugh 评分 7-13 分、出现房室传导阻滞并经内镜止血的患者均符合纳入条件。主要结果是随机分组后 1 年的无移植生存率。次要终点包括 6 周无移植生存率、再出血、严重不良事件、肝硬化的其他并发症、6 个月和 12 个月时的 Child-Pugh 和终末期肝病模型 (MELD) 评分、健康相关生活质量、医疗资源使用情况、成本效益和交叉疗法的使用情况。样本量为294名患者,招募期为4年,涉及英国30家医院:英国国家卫生服务局研究伦理委员会已批准 REACT-AVB(参考编号:23/WM/0085)。研究结果将在同行评审期刊上发表。试验注册号:ISRCTN85274829;方案 3.0 版,2023 年 7 月 1 日。
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引用次数: 0
Attitudes towards transjugular intrahepatic portosystemic shunt (TIPS) in Australia: a national survey of TIPS centres. 澳大利亚对经颈静脉肝内门体分流术(TIPS)的态度:TIPS 中心全国调查。
IF 3.1 Q2 Medicine Pub Date : 2024-03-21 DOI: 10.1136/bmjgast-2023-001308
Eric Kalo, Scott Read, Jacob George, Stuart K Roberts, Avik Majumdar, Golo Ahlenstiel

Background: Transjugular intrahepatic portosystemic shunt (TIPS) is a minimally invasive therapeutic option to treat the sequelae of portal hypertension. It is unclear whether current international recommendations are reflected in current clinical practice across Australia and the extent of variations in care. This study aimed to address this gap in knowledge and benchmark the current landscape of TIPS services in Australia against international guidelines.

Methods: We designed a 42-item questionnaire according to practice-based recommendations and standards of international guidelines to investigate current landscape of TIPS service across four key domains: (1) service provision, (2) patient selection and indications, (3) best procedure practice, and (4) postoperative care.

Results: Gastroenterologist/hepatologists from 23 major liver centres (67.6%) across Australia currently performing TIPS completed the questionnaire. Between 2017 and 2020, there were 456 elective TIPS insertions. Units offering TIPS service had a low median number of TIPS insertions (n=7 per annum). More than half of respondents (56.5%) did not have institutional clinical practice protocols. There was marked variation in practices across institutions in terms of TIPS indications and patient selection. Despite variations, the success rate of elective TIPS was high at 91.7% (79-100%), with 86.6% (29-100%) for rescue TIPS. There was significant variation in postoperative follow-up and care.

Conclusion: Current TIPS practice in Australia varies significantly across institutions. There is a need for a national consensus clinical practice guidelines to improve access and minimise unwarranted variation. A national registry for TIPS could measure, monitor, and report on quality of clinical care and patient outcomes.

背景:经颈静脉肝内门体分流术(TIPS经颈静脉肝内门体分流术(TIPS)是治疗门静脉高压症后遗症的一种微创疗法。目前尚不清楚当前的国际建议是否反映在澳大利亚各地的临床实践中,也不清楚护理中的差异程度。本研究旨在填补这一知识空白,并根据国际指南对澳大利亚 TIPS 服务的现状进行评估:我们根据基于实践的建议和国际指南标准设计了一份 42 个项目的调查问卷,以调查 TIPS 服务在以下四个关键领域的现状:(1)服务提供;(2)患者选择和适应症;(3)最佳手术实践;以及(4)术后护理:来自澳大利亚 23 个主要肝病中心(67.6%)的胃肠病学/肝病学专家完成了问卷调查。2017年至2020年期间,共有456例选择性TIPS插入手术。提供TIPS服务的单位的TIPS插入次数中位数较低(n=7次/年)。超过一半的受访者(56.5%)没有制定机构临床实践协议。各机构在 TIPS 适应症和患者选择方面存在明显差异。尽管存在差异,但选择性 TIPS 的成功率很高,为 91.7% (79-100%),抢救性 TIPS 的成功率为 86.6% (29-100%)。术后随访和护理方面存在很大差异:结论:目前澳大利亚各医疗机构的 TIPS 实践差异很大。有必要制定全国共识的临床实践指南,以改善患者的就医情况,最大限度地减少不必要的差异。全国性的 TIPS 登记处可以对临床护理质量和患者预后进行测量、监控和报告。
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引用次数: 0
Prepublication abstract-only reports compared with full-text manuscripts for randomised controlled trials in inflammatory bowel disease: a systematic review 炎症性肠病随机对照试验的预发表摘要报告与全文稿件比较:系统综述
IF 3.1 Q2 Medicine Pub Date : 2024-03-01 DOI: 10.1136/bmjgast-2023-001334
Vassiliki Sinopoulou, Morris Gordon, Gordon William Moran, Abdullah Mohammed Abousaleh ma Egiz, Sanjana Phlananthachai, Aditi Rane, Ahmed Hussein Ali Al-Tameemi
Introduction Randomised controlled trials (RCTs) of key therapies in inflammatory bowel disease (IBD) are often presented and available as abstracts for significant periods of time prior to full publication, often being employed to make strategic and clinical prescribing decisions. We compared the concordance of prepublication abstract-only reports and their respective full-text manuscripts. Methods Pairs of full-text manuscripts and their respective prepublication abstract-only reports for the same RCT outcomes, at the same time point of analysis were included. The RCTs were on treatments for IBD with full-text manuscripts published between 2010 and 2023. Results We found 77 pairs of full-text manuscripts and their prepublication abstract-only reports. There were significant mismatches in the reporting of stated planned outcomes (65/77 matched, p<0.001) and primary outcomes reported in their results sections (67/77, p<0.001); trial registrations (34/65, p<0.001); the number of randomised participants (49/77, p=0.18); participants reaching end of study (21/71, p<0.001) and primary outcome data (40/73, p<0.001). Authors conclusions matched (75/77, p=0.157). Authors did not provide explicit or implied justifications for the absence or non-concordance for any of the above items. Conclusions Abstract-only reports have consistent issues with both limited reporting of key information and significant differences in data when compared with their later full-text publications. These are not related to further recruitment of patients or word count limitations and are never explained. As abstracts are often used in guidelines, reviews and stakeholder decision-making on prescribing, caution in their use is strongly suggested. Further work is needed to enhance minimum reporting standards in abstract-only works and ensure consistency with final published papers. Data are available on reasonable request. Please contact the corresponding author for data requests.
引言 炎症性肠病(IBD)主要疗法的随机对照试验(RCT)在全文发表前的相当长一段时间内往往以摘要的形式呈现和提供,通常被用于战略和临床处方决策。我们比较了发表前的纯摘要报告与相应的全文手稿的一致性。方法 在同一分析时间点,针对相同的 RCT 结果,纳入成对的全文手稿和各自的预出版纯摘要报告。RCT涉及IBD的治疗方法,全文稿件发表于2010年至2023年之间。结果 我们发现了 77 对全文手稿及其预出版纯摘要报告。在报告所述计划结果(65/77 份匹配,p<0.001)和结果部分报告的主要结果(67/77 份,p<0.001)、试验注册(34/65 份,p<0.001)、随机参与者人数(49/77 份,p=0.18)、研究结束参与者人数(21/71 份,p<0.001)和主要结果数据(40/73 份,p<0.001)方面存在明显的不匹配。作者结论一致(75/77,p=0.157)。作者未就上述任何项目的缺失或不一致提供明确或隐含的理由。结论 仅有摘要的报告与后来的全文出版物相比,始终存在关键信息报告有限和数据差异显著的问题。这些问题与进一步招募患者或字数限制无关,也从未得到解释。由于摘要经常被用于指南、综述和利益相关者的处方决策中,因此强烈建议谨慎使用摘要。还需要进一步努力,提高纯摘要作品的最低报告标准,并确保与最终发表的论文保持一致。如有合理要求,可提供数据。如需数据,请联系通讯作者。
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引用次数: 0
Learning curve of achieving competency in emergency endoscopy in upper gastrointestinal bleeding: how much experience is necessary? 上消化道出血急诊内镜检查能力的学习曲线:需要多少经验?
IF 3.1 Q2 Medicine Pub Date : 2024-03-01 DOI: 10.1136/bmjgast-2023-001281
Gabriel Allo, Sonja Lang, Anna Martin, Martin Bürger, Xinlian Zhang, Seung-Hun Chon, Dirk Nierhoff, Ulrich Töx, Tobias Goeser, Philipp Kasper
Objectives The management of upper gastrointestinal bleeding (UGIB) has seen rapid advancements with revolutionising innovations. However, insufficient data exist on the necessary number of emergency endoscopies needed to achieve competency in haemostatic interventions. Design We retrospectively analysed all oesophagogastroduodenoscopies with signs of recent haemorrhage performed between 2015 and 2022 at our university hospital. A learning curve was created by plotting the number of previously performed oesophagogastroduodenoscopies with signs of recent haemorrhage against the treatment failure rate, defined as failed haemostasis, rebleeding and necessary surgical or radiological intervention. Results The study population included 787 cases with a median age of 66 years. Active bleeding was detected in 576 cases (73.2%). Treatment failure occurred in 225 (28.6%) cases. The learning curve showed a marked decline in treatment failure rates after nine oesophagogastroduodenoscopies had been performed by the respective endoscopists followed by a first plateau between 20 and 50 procedures. A second decline was observed after 51 emergency procedures followed by a second plateau. Endoscopists with experience of <10 emergency procedures had higher treatment failure rates compared with endoscopists with >51 emergency oesophagogastroduodenoscopies performed (p=0.039) or consultants (p=0.041). Conclusions Our data suggest that a minimum number of 20 oesophagogastroduodenoscopies with signs of recent haemorrhage is necessary before endoscopists should be considered proficient to perform emergency procedures independently. Endoscopists might be considered as advanced-qualified experts in managing UGIB after a minimum of 50 haemostatic procedure performed. Implementing recommendations on minimum numbers of emergency endoscopies in education programmes of endoscopy trainees could improve their confidence and competency in managing acute UGIB. Data are available on reasonable request.
目的 上消化道出血(UGIB)的治疗技术突飞猛进,出现了革命性的创新。然而,关于为达到止血干预能力所需的急诊内镜检查次数的数据尚不充分。设计 我们回顾性分析了 2015 年至 2022 年期间在我们大学医院进行的所有有近期出血迹象的食管胃十二指肠镜检查。通过绘制先前进行的有近期出血迹象的食管胃十二指肠镜检查的数量与治疗失败率(定义为止血失败、再出血和必要的外科或放射介入治疗)之间的学习曲线。结果 研究对象包括 787 个病例,中位年龄为 66 岁。发现活动性出血的病例有 576 例(73.2%)。225例(28.6%)治疗失败。学习曲线显示,在各内镜医师进行了九次食管胃十二指肠镜检查后,治疗失败率明显下降,随后在20至50次手术之间出现了第一个高点。在进行了 51 次急诊手术后,治疗失败率出现第二次下降,随后达到第二个高峰。内镜医师的急诊食管胃十二指肠镜检查次数达到51次(P=0.039),顾问的急诊食管胃十二指肠镜检查次数达到51次(P=0.041)。结论 我们的数据表明,内镜医师至少要进行过20次有近期出血迹象的食管胃十二指肠镜检查,才能被认为能够熟练地独立进行急诊手术。内镜医师在完成至少 50 次止血手术后,可被视为处理 UGIB 的高级合格专家。在内镜受训人员的教育计划中实施有关急诊内镜手术最低次数的建议,可提高他们处理急性 UGIB 的信心和能力。如有合理要求,可提供相关数据。
{"title":"Learning curve of achieving competency in emergency endoscopy in upper gastrointestinal bleeding: how much experience is necessary?","authors":"Gabriel Allo, Sonja Lang, Anna Martin, Martin Bürger, Xinlian Zhang, Seung-Hun Chon, Dirk Nierhoff, Ulrich Töx, Tobias Goeser, Philipp Kasper","doi":"10.1136/bmjgast-2023-001281","DOIUrl":"https://doi.org/10.1136/bmjgast-2023-001281","url":null,"abstract":"Objectives The management of upper gastrointestinal bleeding (UGIB) has seen rapid advancements with revolutionising innovations. However, insufficient data exist on the necessary number of emergency endoscopies needed to achieve competency in haemostatic interventions. Design We retrospectively analysed all oesophagogastroduodenoscopies with signs of recent haemorrhage performed between 2015 and 2022 at our university hospital. A learning curve was created by plotting the number of previously performed oesophagogastroduodenoscopies with signs of recent haemorrhage against the treatment failure rate, defined as failed haemostasis, rebleeding and necessary surgical or radiological intervention. Results The study population included 787 cases with a median age of 66 years. Active bleeding was detected in 576 cases (73.2%). Treatment failure occurred in 225 (28.6%) cases. The learning curve showed a marked decline in treatment failure rates after nine oesophagogastroduodenoscopies had been performed by the respective endoscopists followed by a first plateau between 20 and 50 procedures. A second decline was observed after 51 emergency procedures followed by a second plateau. Endoscopists with experience of <10 emergency procedures had higher treatment failure rates compared with endoscopists with >51 emergency oesophagogastroduodenoscopies performed (p=0.039) or consultants (p=0.041). Conclusions Our data suggest that a minimum number of 20 oesophagogastroduodenoscopies with signs of recent haemorrhage is necessary before endoscopists should be considered proficient to perform emergency procedures independently. Endoscopists might be considered as advanced-qualified experts in managing UGIB after a minimum of 50 haemostatic procedure performed. Implementing recommendations on minimum numbers of emergency endoscopies in education programmes of endoscopy trainees could improve their confidence and competency in managing acute UGIB. Data are available on reasonable request.","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140056793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy of TIPS plus extrahepatic collateral embolisation in real-world data: a validation study. 真实世界数据中 TIPS 加肝外旁路栓塞的疗效:一项验证研究。
IF 3.1 Q2 Medicine Pub Date : 2024-02-23 DOI: 10.1136/bmjgast-2023-001310
Lianhui Zhao, Jun Tie, Guangchuan Wang, Zhengjie Li, Jiao Xu, Yuzheng Zhuge, Feng Zhang, Hao Wu, Bo Wei, Hui Xue, Peijie Li, Wei Wu, Chao Chen, Qiong Wu, Yifu Xia, Xiubin Sun, Chunqing Zhang

Objectives: The efficacy of transjugular intrahepatic portosystemic shunt (TIPS) plus extrahepatic collateral embolisation (TIPS+E) in reducing rebleeding and hepatic encephalopathy (HE) post-TIPS was recently reported in a meta-analysis, but further validation is essential. This study aims to confirm the effectiveness of TIPS+E using real-world data.

Methods: The multicentre retrospective cohort included 2077 patients with cirrhosis who underwent TIPS±E (TIPS: 631, TIPS+E: 1446) between January 2010 and December 2022. Regression and propensity score matching (PSM) were used to adjust for baseline characteristic differences. After PSM, clinical outcomes, including rebleeding, HE, survival and further decompensation (FDC), were analysed. Baseline data from all patients contributed to the construction of prognostic models.

Results: After PSM, 1136 matched patients (TIPS+E: TIPS=568:568) were included. TIPS+E demonstrated a significant reduction in rebleeding (HR 0.77; 95% CI 0.59 to 0.99; p=0.04), HE (HR 0.82; 95% CI 0.68 to 0.99; p=0.04) and FDC (HR 0.85; 95% CI 0.73 to 0.99; p=0.04), comparing to TIPS. Significantly, TIPS+E also reduced rebleeding, HE and FDC in subgroup of using 8 mm diameter stents and embolising of gastric varices+spontaneous portosystemic shunts (GV+SPSS). However, there were no differences in overall or subgroup survival analysis. Additionally, the random forest models showed higher accuracy and AUROC comparing to other models. Controlling post-TIPS portal pressure gradient (pPPG) within 7 mm Hg

Conclusion: Our real-world data validation confirms the high efficacy of TIPS+E in reducing rebleeding and HE, particularly when using 8 mm diameter stents, embolising GV+SPSS and maintaining an optimal pPPG.

研究目的最近一项荟萃分析报告了经颈静脉肝内门体系统分流术(TIPS)加肝外副栓塞术(TIPS+E)在减少TIPS术后再出血和肝性脑病(HE)方面的疗效,但进一步的验证至关重要。本研究旨在利用真实世界的数据证实 TIPS+E 的有效性:多中心回顾性队列包括2010年1月至2022年12月期间接受TIPS±E治疗的2077例肝硬化患者(TIPS:631例,TIPS+E:1446例)。采用回归和倾向评分匹配(PSM)来调整基线特征差异。经过倾向得分匹配后,对包括再出血、高血压、存活率和进一步失代偿(FDC)在内的临床结果进行了分析。所有患者的基线数据都有助于构建预后模型:结果:经过 PSM,共纳入了 1136 例匹配患者(TIPS+E:TIPS=568:568)。与 TIPS 相比,TIPS+E 能显著减少再出血(HR 0.77;95% CI 0.59 至 0.99;P=0.04)、HE(HR 0.82;95% CI 0.68 至 0.99;P=0.04)和 FDC(HR 0.85;95% CI 0.73 至 0.99;P=0.04)。在使用直径 8 毫米支架和栓塞胃静脉曲张+自发性门静脉分流术(GV+SPSS)的亚组中,TIPS+E 也显著减少了再出血、HE 和 FDC。然而,总体或亚组生存率分析没有差异。此外,与其他模型相比,随机森林模型显示出更高的准确性和AUROC。将 TIPS 术后门静脉压力阶差(pPPG)控制在 7 毫米汞柱以内:我们的真实世界数据验证证实了 TIPS+E 在减少再出血和 HE 方面的高效性,尤其是在使用直径 8 毫米的支架、栓塞 GV+SPSS 并保持最佳 pPPG 的情况下。
{"title":"Efficacy of TIPS plus extrahepatic collateral embolisation in real-world data: a validation study.","authors":"Lianhui Zhao, Jun Tie, Guangchuan Wang, Zhengjie Li, Jiao Xu, Yuzheng Zhuge, Feng Zhang, Hao Wu, Bo Wei, Hui Xue, Peijie Li, Wei Wu, Chao Chen, Qiong Wu, Yifu Xia, Xiubin Sun, Chunqing Zhang","doi":"10.1136/bmjgast-2023-001310","DOIUrl":"10.1136/bmjgast-2023-001310","url":null,"abstract":"<p><strong>Objectives: </strong>The efficacy of transjugular intrahepatic portosystemic shunt (TIPS) plus extrahepatic collateral embolisation (TIPS+E) in reducing rebleeding and hepatic encephalopathy (HE) post-TIPS was recently reported in a meta-analysis, but further validation is essential. This study aims to confirm the effectiveness of TIPS+E using real-world data.</p><p><strong>Methods: </strong>The multicentre retrospective cohort included 2077 patients with cirrhosis who underwent TIPS±E (TIPS: 631, TIPS+E: 1446) between January 2010 and December 2022. Regression and propensity score matching (PSM) were used to adjust for baseline characteristic differences. After PSM, clinical outcomes, including rebleeding, HE, survival and further decompensation (FDC), were analysed. Baseline data from all patients contributed to the construction of prognostic models.</p><p><strong>Results: </strong>After PSM, 1136 matched patients (TIPS+E: TIPS=568:568) were included. TIPS+E demonstrated a significant reduction in rebleeding (HR 0.77; 95% CI 0.59 to 0.99; p=0.04), HE (HR 0.82; 95% CI 0.68 to 0.99; p=0.04) and FDC (HR 0.85; 95% CI 0.73 to 0.99; p=0.04), comparing to TIPS. Significantly, TIPS+E also reduced rebleeding, HE and FDC in subgroup of using 8 mm diameter stents and embolising of gastric varices+spontaneous portosystemic shunts (GV+SPSS). However, there were no differences in overall or subgroup survival analysis. Additionally, the random forest models showed higher accuracy and AUROC comparing to other models. Controlling post-TIPS portal pressure gradient (pPPG) within 7 mm Hg<pPPG<8.5 mm Hg improved prognosis, especially in TIPS+E group.</p><p><strong>Conclusion: </strong>Our real-world data validation confirms the high efficacy of TIPS+E in reducing rebleeding and HE, particularly when using 8 mm diameter stents, embolising GV+SPSS and maintaining an optimal pPPG.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10895241/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139939713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Role of exhaled hydrogen sulfide in the diagnosis of colorectal cancer. 呼出硫化氢在诊断结直肠癌中的作用。
IF 3.1 Q2 Medicine Pub Date : 2024-02-20 DOI: 10.1136/bmjgast-2023-001229
Peizhun Du, Yujen Tseng, Pengcheng Liu, Huilu Zhang, Guangjian Huang, Cheng'en Hu, Jian Chen

Background: Colorectal cancer (CRC) is often accompanied by increased excretion of hydrogen sulfide (H2S). This study aimed to explore the value of exhaled H2S in the diagnosis of CRC.

Methods: A total of 80 people with normal colonoscopy results and 57 patients with CRC were enrolled into the present observational cohort study. Exhaled oral and nasal H2S were detected by Nanocoulomb breath analyser. Results were compared between the two groups. Receiver operating characteristic (ROC) curves were analysed and area under the curves (AUCs) were calculated to assess the diagnostic value of exhaled H2S. Meanwhile, the clinicopathological features, including gender, lesion location and tumour staging of patients with CRC, were also collected and analysed.

Results: The amount of exhaled H2S from patients with CRC was significantly higher than that of those with normal colonoscopy results. The ROC curve showed an AUC value of 0.73 and 0.71 based on oral and nasal H2S detection, respectively. The exhaled H2S in patients with CRC was correlated with gender, lesion location and tumour progression, including depth of invasion, lymphatic metastasis and TNM (Tumor, Lymph Nodes, Metastasis) staging.

Conclusion: Exhaled H2S analysis is a convenient and non-invasive detection method for diagnosing CRC, suggesting a potential role in population screening for CRC.

背景:大肠癌(CRC)通常伴有硫化氢(H2S)排泄增加。本研究旨在探讨呼出的 H2S 在诊断 CRC 中的价值:本观察性队列研究共纳入了 80 名结肠镜检查结果正常者和 57 名 CRC 患者。采用 Nanocoulomb 呼气分析仪检测口腔和鼻腔呼出的 H2S。两组结果进行了比较。分析了接收者操作特征曲线(ROC),并计算了曲线下面积(AUC),以评估呼出的 H2S 的诊断价值。同时,还收集并分析了 CRC 患者的临床病理特征,包括性别、病变部位和肿瘤分期:结果:CRC 患者呼出的 H2S 量明显高于结肠镜检查结果正常的患者。根据口腔和鼻腔 H2S 检测结果,ROC 曲线的 AUC 值分别为 0.73 和 0.71。结论:CRC 患者呼出的 H2S 与性别、病灶位置和肿瘤进展(包括侵犯深度、淋巴转移和 TNM(肿瘤、淋巴结、转移)分期)相关:结论:呼出的 H2S 分析是诊断 CRC 的一种方便、无创的检测方法,它在人群 CRC 筛查中具有潜在的作用。
{"title":"Role of exhaled hydrogen sulfide in the diagnosis of colorectal cancer.","authors":"Peizhun Du, Yujen Tseng, Pengcheng Liu, Huilu Zhang, Guangjian Huang, Cheng'en Hu, Jian Chen","doi":"10.1136/bmjgast-2023-001229","DOIUrl":"10.1136/bmjgast-2023-001229","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) is often accompanied by increased excretion of hydrogen sulfide (H<sub>2</sub>S). This study aimed to explore the value of exhaled H<sub>2</sub>S in the diagnosis of CRC.</p><p><strong>Methods: </strong>A total of 80 people with normal colonoscopy results and 57 patients with CRC were enrolled into the present observational cohort study. Exhaled oral and nasal H<sub>2</sub>S were detected by Nanocoulomb breath analyser. Results were compared between the two groups. Receiver operating characteristic (ROC) curves were analysed and area under the curves (AUCs) were calculated to assess the diagnostic value of exhaled H<sub>2</sub>S. Meanwhile, the clinicopathological features, including gender, lesion location and tumour staging of patients with CRC, were also collected and analysed.</p><p><strong>Results: </strong>The amount of exhaled H<sub>2</sub>S from patients with CRC was significantly higher than that of those with normal colonoscopy results. The ROC curve showed an AUC value of 0.73 and 0.71 based on oral and nasal H<sub>2</sub>S detection, respectively. The exhaled H<sub>2</sub>S in patients with CRC was correlated with gender, lesion location and tumour progression, including depth of invasion, lymphatic metastasis and TNM (Tumor, Lymph Nodes, Metastasis) staging.</p><p><strong>Conclusion: </strong>Exhaled H<sub>2</sub>S analysis is a convenient and non-invasive detection method for diagnosing CRC, suggesting a potential role in population screening for CRC.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10882367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biological therapy for inflammatory bowel disease: cyclical rather than lifelong treatment? 炎症性肠病的生物疗法:周期性治疗而非终身治疗?
IF 3.1 Q2 Medicine Pub Date : 2024-02-10 DOI: 10.1136/bmjgast-2023-001225
Christian Philipp Selinger, Konstantina Rosiou, Marco V Lenti

Inflammatory bowel disease (IBD) treatment was revolutionised with the arrival of biological therapy two decades ago. There are now multiple biologics and increasingly novel small molecules licensed for the treatment of IBD. Treatment guidelines highlight the need for effective control of inflammation and early escalation to advanced therapies to avoid long-term complications. Consequently, a large proportion of patients with IBD receive advanced therapies for a long time. Despite their beneficial risk-benefit profile, these treatments are not without risk of side effects, are costly to healthcare providers and pose a burden to the patient. It is, therefore, paramount to examine in which circumstances a temporary cessation of therapy can be attempted without undue clinical risk. Some patients may benefit from cyclical rather than continuous treatment. This review examines the risk of relapse after discontinuation of advanced therapies, how to identify patients at the lowest risk of relapse and the chance of recapturing response when flaring after discontinuation.

二十年前,生物疗法的出现彻底改变了炎症性肠病(IBD)的治疗。现在,已有多种生物制剂和越来越多的新型小分子药物获得了治疗 IBD 的许可。治疗指南强调,必须有效控制炎症并尽早升级到先进疗法,以避免长期并发症。因此,很大一部分 IBD 患者长期接受先进疗法。尽管这些疗法具有良好的风险收益特征,但并非没有副作用风险,而且对医疗服务提供者来说成本高昂,对患者来说也是一种负担。因此,最重要的是研究在哪些情况下可以尝试暂时停止治疗,而不会带来不必要的临床风险。有些患者可能会从周期性治疗而非持续治疗中获益。本综述探讨了停用先进疗法后复发的风险、如何识别复发风险最低的患者以及停药后病情复发时重新获得应答的机会。
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引用次数: 0
Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. 确定溃疡性结肠炎患者的最佳治疗目标:随机对照 VERDICT 试验的原理、设计、方案和中期分析。
IF 3.1 Q2 Medicine Pub Date : 2024-02-08 DOI: 10.1136/bmjgast-2023-001218
Vipul Jairath, Guangyong Zou, Zhongya Wang, Shashi Adsul, Jean-Frederic Colombel, Geert R D'Haens, Marcelo Freire, Gordon W Moran, Laurent Peyrin-Biroulet, William J Sandborn, Shaji Sebastian, Simon Travis, Séverine Vermeire, Gabriela Radulescu, Julie Sigler, Jurij Hanžel, Christopher Ma, Rocio Sedano, Stefanie C McFarlane, Naveen Arya, Melanie Beaton, Peter Bossuyt, Silvio Danese, Daniel Green, William Harlan, Marek Horynski, Maria Klopocka, Rima Petroniene, Mark S Silverberg, Lukasz Wolanski, Brian G Feagan

Introduction: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC.

Methods and analysis: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model.

Ethics and dissemination: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings.

Trial registration number: EudraCT: 2019-002485-12; NCT04259138.

简介:溃疡性结肠炎(UC)的治疗目标包括症状、内镜检查和组织学检查。观察性研究表明,与仅获得内镜下缓解相比,获得组织学缓解可能与较低的并发症风险相关。溃疡性结肠炎行动对照试验(VERDICT)旨在确定 UC 患者的最佳治疗目标:在这项多中心、前瞻性随机研究中,660 名中重度 UC 患者(梅奥直肠出血评分[RBS] ≥1;梅奥内镜评分[MES] ≥2)被随机分配到三种治疗目标:无皮质类固醇症状缓解(梅奥 RBS=0)(第 1 组);无皮质类固醇内镜缓解(MES ≤1)和症状缓解(第 2 组);或无皮质类固醇组织学缓解(Geboes 评分 伦理和传播:该研究已获得国家级伦理委员会的批准,或根据各个国家的要求获得个别研究地点伦理委员会的批准。伦理委员会的完整名单可向我们索取。研究结果将在同行评审期刊和科学会议上公布:EudraCT: 2019-002485-12; NCT04259138.
{"title":"Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial.","authors":"Vipul Jairath, Guangyong Zou, Zhongya Wang, Shashi Adsul, Jean-Frederic Colombel, Geert R D'Haens, Marcelo Freire, Gordon W Moran, Laurent Peyrin-Biroulet, William J Sandborn, Shaji Sebastian, Simon Travis, Séverine Vermeire, Gabriela Radulescu, Julie Sigler, Jurij Hanžel, Christopher Ma, Rocio Sedano, Stefanie C McFarlane, Naveen Arya, Melanie Beaton, Peter Bossuyt, Silvio Danese, Daniel Green, William Harlan, Marek Horynski, Maria Klopocka, Rima Petroniene, Mark S Silverberg, Lukasz Wolanski, Brian G Feagan","doi":"10.1136/bmjgast-2023-001218","DOIUrl":"10.1136/bmjgast-2023-001218","url":null,"abstract":"<p><strong>Introduction: </strong>Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC.</p><p><strong>Methods and analysis: </strong>In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model.</p><p><strong>Ethics and dissemination: </strong>The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings.</p><p><strong>Trial registration number: </strong>EudraCT: 2019-002485-12; NCT04259138.</p>","PeriodicalId":9235,"journal":{"name":"BMJ Open Gastroenterology","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10870790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139711524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
CD, or not CD, that is the question: a digital interobserver agreement study in coeliac disease 是 CD,还是不是 CD,这就是问题所在:一项关于乳糜泻的数字观察者间一致性研究
IF 3.1 Q2 Medicine Pub Date : 2024-02-01 DOI: 10.1136/bmjgast-2023-001252
James Denholm, Benjamin A Schreiber, Florian Jaeckle, Mike N Wicks, Emyr W Benbow, Tim S Bracey, James Y H Chan, Lorant Farkas, Eve Fryer, Kishore Gopalakrishnan, Caroline A Hughes, Kathryn J Kirkwood, Gerald Langman, Betania Mahler-Araujo, Raymond F T McMahon, Khun La Win Myint, Sonali Natu, Andrew Robinson, Ashraf Sanduka, Katharine A Sheppard, Yee Wah Tsang, Mark J Arends, Elizabeth J Soilleux
Objective Coeliac disease (CD) diagnosis generally depends on histological examination of duodenal biopsies. We present the first study analysing the concordance in examination of duodenal biopsies using digitised whole-slide images (WSIs). We further investigate whether the inclusion of immunoglobulin A tissue transglutaminase (IgA tTG) and haemoglobin (Hb) data improves the interobserver agreement of diagnosis. Design We undertook a large study of the concordance in histological examination of duodenal biopsies using digitised WSIs in an entirely virtual reporting setting. Our study was organised in two phases: in phase 1, 13 pathologists independently classified 100 duodenal biopsies (40 normal; 40 CD; 20 indeterminate enteropathy) in the absence of any clinical or laboratory data. In phase 2, the same pathologists examined the (re-anonymised) WSIs with the inclusion of IgA tTG and Hb data. Results We found the mean probability of two observers agreeing in the absence of additional data to be 0.73 (±0.08) with a corresponding Cohen’s kappa of 0.59 (±0.11). We further showed that the inclusion of additional data increased the concordance to 0.80 (±0.06) with a Cohen’s kappa coefficient of 0.67 (±0.09). Conclusion We showed that the addition of serological data significantly improves the quality of CD diagnosis. However, the limited interobserver agreement in CD diagnosis using digitised WSIs, even after the inclusion of IgA tTG and Hb data, indicates the importance of interpreting duodenal biopsy in the appropriate clinical context. It further highlights the unmet need for an objective means of reproducible duodenal biopsy diagnosis, such as the automated analysis of WSIs using artificial intelligence. No data are available. The raw data, along with the code and instructions for reproducing all of the analysis and figures presented in this work are available in THIS GITLAB REPOSITORY (). We are not at liberty to share the WSIs, however.
目的:乳糜泻(CD)的诊断通常取决于十二指肠活检组织学检查。我们首次利用数字化全切片图像(WSI)对十二指肠活检组织检查的一致性进行了分析。我们还进一步研究了加入免疫球蛋白 A 组织转谷氨酰胺酶(IgA tTG)和血红蛋白(Hb)数据是否能提高观察者之间的诊断一致性。设计 我们在完全虚拟的报告环境中使用数字化 WSI 对十二指肠活检组织学检查的一致性进行了一项大型研究。我们的研究分为两个阶段:在第一阶段,13 位病理学家在没有任何临床或实验室数据的情况下独立对 100 例十二指肠活检组织(40 例正常;40 例 CD;20 例不确定肠病)进行了分类。在第 2 阶段,同样的病理学家在加入 IgA tTG 和 Hb 数据后检查了(重新匿名的)WSI。结果 我们发现,在没有额外数据的情况下,两名观察者达成一致的平均概率为 0.73 (±0.08),相应的 Cohen's kappa 为 0.59 (±0.11)。我们进一步发现,加入额外数据后,一致性提高到 0.80 (±0.06),科恩卡帕系数为 0.67 (±0.09)。结论 我们的研究表明,加入血清学数据可显著提高 CD 诊断的质量。然而,即使在加入 IgA tTG 和 Hb 数据后,使用数字化 WSI 诊断 CD 的观察者间一致性仍然有限,这表明在适当的临床背景下解释十二指肠活检的重要性。这进一步凸显了对可重复十二指肠活检诊断客观方法的需求尚未得到满足,例如使用人工智能对 WSI 进行自动分析。无数据可用。原始数据、代码以及重现所有分析和图表的说明均可在本 GITLAB REPOSITORY () 中获取。不过,我们不能随意分享 WSI。
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引用次数: 0
Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. 人工智能辅助结肠镜检查在临床实践中的影响:前瞻性随机对照试验。
IF 3.1 Q2 Medicine Pub Date : 2024-01-30 DOI: 10.1136/bmjgast-2023-001247
Johanna Schöler, Marko Alavanja, Thomas de Lange, Shunsuke Yamamoto, Per Hedenström, Jonas Varkey

Objective: Colorectal cancer (CRC) has a significant role in cancer-related mortality. Colonoscopy, combined with adenoma removal, has proven effective in reducing CRC incidence. However, suboptimal colonoscopy quality often leads to missed polyps. The impact of artificial intelligence (AI) on adenoma and polyp detection rate (ADR, PDR) is yet to be established.

Design: We conducted a randomised controlled trial at Sahlgrenska University Hospital in Sweden. Patients underwent colonoscopy with or without the assistance of AI (AI-C or conventional colonoscopy (CC)). Examinations were performed with two different AI systems, that is, Fujifilm CADEye and Medtronic GI Genius. The primary outcome was ADR.

Results: Among 286 patients, 240 underwent analysis (average age: 66 years). The ADR was 42% for all patients, and no significant difference emerged between AI-C and CC groups (41% vs 43%). The overall PDR was 61%, with a trend towards higher PDR in the AI-C group. Subgroup analysis revealed higher detection rates for sessile serrated lesions (SSL) with AI assistance (AI-C 22%, CC 11%, p=0.004). No difference was noticed in the detection of polyps or adenomas per colonoscopy. Examinations were most often performed by experienced endoscopists, 78% (n=86 AI-C, 100 CC).

Conclusion: Amidst the ongoing AI integration, ADR did not improve with AI. Particularly noteworthy is the enhanced detection rates for SSL by AI assistance, especially since they pose a risk for postcolonoscopy CRC. The integration of AI into standard colonoscopy practice warrants further investigation and the development of improved software might be necessary before enforcing its mandatory implementation.

Trial registration number: NCT05178095.

目的:结肠直肠癌(CRC)在癌症相关死亡率中占有重要地位。事实证明,结肠镜检查结合腺瘤切除术可有效降低 CRC 发病率。然而,结肠镜检查质量不达标往往会导致漏诊息肉。人工智能(AI)对腺瘤和息肉检出率(ADR、PDR)的影响尚未确定:设计:我们在瑞典 Sahlgrenska 大学医院进行了一项随机对照试验。患者在有人工智能辅助或无人工智能辅助的情况下接受结肠镜检查(AI-C 或传统结肠镜检查 (CC))。检查由两种不同的人工智能系统进行,即富士胶片 CADEye 和美敦力 GI Genius。主要结果是 ADR:在 286 名患者中,240 人接受了分析(平均年龄:66 岁)。所有患者的 ADR 为 42%,AI-C 组和 CC 组之间无明显差异(41% 对 43%)。总体 PDR 为 61%,AI-C 组的 PDR 呈上升趋势。亚组分析显示,在 AI 辅助下,无柄锯齿状病变(SSL)的检出率更高(AI-C 组 22%,CC 组 11%,P=0.004)。在每次结肠镜检查中,息肉或腺瘤的检出率没有差异。检查通常由经验丰富的内镜医师进行,占 78%(n=86 AI-C,100 CC):结论:在人工智能不断融合的过程中,ADR 并未随着人工智能的发展而改善。特别值得注意的是,人工智能辅助提高了 SSL 的检出率,尤其是因为 SSL 会带来结肠镜检查后患上 CRC 的风险。将人工智能整合到标准结肠镜检查实践中值得进一步研究,在强制实施前可能需要开发改进的软件:NCT05178095.
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引用次数: 0
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BMJ Open Gastroenterology
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