预防性内镜夹放置对右半结肠内镜黏膜切除术后临床显著出血的影响：一项单中心、随机对照试验。
Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial.
机构信息
Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; Westmead Clinical School, University of Sydney, Sydney, NSW, Australia.
Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, NSW, Australia; Westmead Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Medicine, University of British Columbia, Vancouver, Canada.
出版信息
Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18.
BACKGROUND
Endoscopic mucosal resection (EMR) is a cornerstone in the management of large (≥20 mm) non-pedunculated colorectal polyps. Clinically significant post-EMR bleeding occurs in 7% of cases and is most frequently encountered in the right colon. We aimed to assess the use of prophylactic clip closure in preventing clinically significant post-EMR bleeding within the right colon.
METHODS
We conducted a randomised controlled trial at a tertiary centre in Australia. Patients referred for the EMR of large non-pedunculated colorectal polyps in the right colon were eligible. Patients were randomly assigned (1:1) into the clip or control (no clip) group, using a computerised random-number generator. The primary endpoint was clinically significant post-EMR bleeding, defined as haematochezia necessitating emergency department presentation, hospitalisation, or re-intervention within 14 days post-EMR, which was analysed on the basis of intention-to-treat principles. The trial is registered with ClinicalTrials.gov, NCT02196649, and has been completed.
FINDINGS
Between Feb 4, 2016, and Dec 15, 2020, 231 patients were randomly assigned: 118 to the clip group and 113 to the control group. In the intention-to-treat analysis, clinically significant post-EMR bleeding was less frequent in the clip group than in the control group (four [3·4%] of 118 patients vs 12 [10·6%] of 113; p=0·031; absolute risk reduction 7·2% [95% CI 0·7-13·8]; number needed to treat 13·9). There were no differences between groups in adverse events, including delayed perforation (one [<1%] in the clip group vs one [<1%] in the control group) and post-EMR pain (four [3%] vs six [5%]). No deaths were reported.
INTERPRETATION
Prophylactic clip closure can be performed following the EMR of large non-pedunculated colorectal polyps of 20 mm or larger in the right colon to reduce the risk of clinically significant post-EMR bleeding.
FUNDING
None.
背景
内镜黏膜切除术（EMR）是治疗大型（≥20mm）无蒂结直肠息肉的基石。临床上，EMR 后出血发生率为 7%，且最常发生于右半结肠。我们旨在评估预防性夹闭在预防右半结肠 EMR 后临床显著出血中的作用。
方法
我们在澳大利亚的一家三级中心进行了一项随机对照试验。符合条件的患者为右半结肠接受大型无蒂结直肠息肉 EMR 治疗。患者按照 1:1 的比例随机分配（使用计算机生成的随机数字发生器）进入夹闭组或对照组（不夹闭）。主要终点是 EMR 后临床显著出血，定义为 EMR 后 14 天内需要急诊就诊、住院或再次干预的血便，基于意向治疗原则进行分析。该试验在 ClinicalTrials.gov 注册，NCT02196649，现已完成。
结果
2016 年 2 月 4 日至 2020 年 12 月 15 日期间，共有 231 名患者被随机分配：夹闭组 118 名，对照组 113 名。意向治疗分析显示，夹闭组 EMR 后临床显著出血的发生率低于对照组（夹闭组 4 例[3.4%]，对照组 12 例[10.6%]；p=0.031；绝对风险降低 7.2%[95%CI 0.7-13.8]；需要治疗的人数 13.9）。两组间的不良事件无差异，包括延迟穿孔（夹闭组 1 例[<1%]，对照组 1 例[<1%]）和 EMR 后疼痛（夹闭组 4 例[3%]，对照组 6 例[5%]）。未报告死亡病例。
结论
预防性夹闭可在右半结肠 20mm 或更大的大型无蒂结直肠息肉 EMR 后进行，以降低 EMR 后临床显著出血的风险。
试验注册
无。
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