Multicentre randomised controlled trial of a self-assembling haemostatic gel to prevent delayed bleeding following endoscopic mucosal resection (PURPLE Trial)

IF 23 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gut Pub Date : 2025-02-23 DOI:10.1136/gutjnl-2024-334229
Jan Drews, Markus Zachäus, Tobias Kleemann, Jörg Schirra, Oscar Cahyadi, Oliver Möschler, Christian Schulze, Ingo Steinbrück, Edris Wedi, Oliver Pech, Tobias J Weismüller, Armin Küllmer, Mohamed Abdelhafez, Jochen Wedemeyer, Torsten Beyna, Julian Riedel, Ulrich Paul Halm, Carola Güther, Riccardo Vasapolli, Christian Torres Reyes, Daniel R Quast, Oliver Bachmann, Erini Dedonaki, Jörg Ulrich, Inna Marchuk, Christina Frahm, Tanja Steffen, Peter Wohlmuth, Torsten Bunde, Nele Geßler, Thomas von Hahn
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Abstract

Background Prophylactic application of a haemostatic gel to the resection field may be an easy way to prevent delayed bleeding, a frequent complication after endoscopic mucosal resection (EMR). Objective We aimed to evaluate if the prophylactic application of a haemostatic gel to the resection field directly after EMR can reduce the rate of clinically significant delayed bleeding events. Design We conducted a prospective randomised trial of patients undergoing hot-snare EMR of flat lesions in the duodenum (≥10 mm) and colorectum (≥20 mm) at 15 German centres. Prophylactic clip closure was not allowed, but selective clipping or coagulation could be used prior to randomisation to treat intraprocedural bleeding or for prophylactic closure of visible vessels. Patients were randomised to haemostatic gel application or no prophylaxis. The primary endpoint was delayed bleeding within 30 days. Results The trial was stopped early due to futility after an interim analysis. The primary endpoint was analysed in 232 patients (208 colorectal, 26 duodenal). Both groups were comparable in age, sex, comorbidities and lesion characteristics. Preventive measures, such as selective clipping or coagulation, were applied prior to randomisation in 51.9% of cases, with no difference between groups. Delayed bleeding occurred in 14 cases (11.7%; 95% CI 7.1% to 18.6%) after Purastat and in 7 cases (6.3%; 95% CI 3.1% to 12.3%) in the control group (p=0.227), with no difference between colorectal and duodenal subgroups. Conclusion The application of a haemostatic gel following EMR of large flat lesions in the duodenum and colorectum does not reduce the rate of delayed bleeding. Data are available on reasonable request. Data and full trial protocol are available on reasonable request. All data relevant to the study are included in the article of uploaded as online supplemental information.
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背景 在切除区域预防性使用止血凝胶可能是防止延迟出血的一种简便方法,延迟出血是内镜粘膜切除术(EMR)后经常出现的一种并发症。目的 我们旨在评估在内镜粘膜切除术后直接在切除区域预防性使用止血凝胶是否能降低具有临床意义的延迟出血事件的发生率。设计 我们在 15 个德国中心对接受十二指肠(≥10 毫米)和结直肠(≥20 毫米)扁平病变热镜 EMR 的患者进行了前瞻性随机试验。不允许进行预防性夹闭,但可在随机化之前进行选择性夹闭或凝固,以治疗术中出血或预防性封闭可见血管。患者被随机分配使用止血凝胶或不使用预防措施。主要终点是30天内的延迟出血。结果 试验在中期分析后因无效而提前终止。对 232 名患者(208 名结直肠患者,26 名十二指肠患者)的主要终点进行了分析。两组患者在年龄、性别、合并症和病变特征方面具有可比性。51.9%的病例在随机分组前采取了预防措施,如选择性剪切或凝血,组间无差异。普拉斯他治疗后有14例(11.7%;95% CI 7.1%至18.6%)发生延迟出血,对照组有7例(6.3%;95% CI 3.1%至12.3%)(P=0.227),结直肠和十二指肠亚组之间无差异。结论 对十二指肠和结直肠大面积扁平病变进行 EMR 后使用止血凝胶不会降低延迟出血率。如有合理要求,可提供相关数据。如有合理要求,可提供数据和完整的试验方案。与该研究相关的所有数据均作为在线补充信息上载到文章中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Gut
Gut 医学-胃肠肝病学
CiteScore
45.70
自引率
2.40%
发文量
284
审稿时长
1.5 months
期刊介绍: Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.
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