BACKGROUND AND AIMS Post endoscopic submucosal dissection coagulation syndrome (PECS) occasionally occurs after colorectal endoscopic submucosal dissection (ESD), presenting with localized abdominal pain and inflammation. We conducted a randomized controlled trial (RCT) to assess the usefulness of endoscopic clipping closure to prevent PECS and delayed perforation (DP). METHODS This is a multicenter, single-blind RCT. Prospectively enrolled patients undergoing colorectal ESD were randomly allocated to endoscopic clipping closure and nonclosure after ESD, stratifying by institution and tumor size. All participants underwent a computed tomography scan after ESD. PECS was defined as visual analog scale (VAS) ≥30 mm, an increase in VAS ≥20 mm from baseline, body temperature ≥37.5°C or white blood cells ≥10,000/μL after colorectal ESD. DP was defined as PECS accompanied by extraluminal air. The preplanned sample size was 320 patients, and the primary endpoint was the rate of PECS/DP. RESULTS At the planned interim analysis, this trial was terminated by recommendation of the independent data and safety monitoring committee because conditional power with superiority was lower than the preplanned futility limit. Finally, 155 patients were analyzed. The rate of PECS/DP was 16% (95% confidence interval [CI], 8%-23%) in the nonclosure group and 24% (95% CI, 14%-34%) in the closure group (P = .184). All cases of DP were within minor criteria, and all PECS/DP patients were managed conservatively without surgical treatment. Simple periluminal air without PECS was observed in 16% (95% CI, 8%-23%) in the nonclosure group and 10% (95% CI, 3%-17%) in the closure group. CONCLUSION Endoscopic clipping closure could not reduce the high incidence of PECS/DP after colorectal ESD. (University Hospital Medical Network Clinical Trials Registry number: UMIN000027031.).

中文翻译：

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一项多中心，单盲的内镜下夹闭术预防大肠内镜黏膜下剥离术后凝血综合征的随机对照试验。

背景与目的结直肠内窥镜黏膜下剥离术（ESD）后偶尔会发生内镜下黏膜下剥离凝结综合症（PECS），表现为局部腹痛和炎症。我们进行了一项随机对照试验（RCT），以评估内窥镜钳夹闭合预防PECS和延迟穿孔（DP）的有效性。方法这是一个多中心，单盲RCT。接受结直肠ESD治疗的前瞻性患者被随机分配到ESD术后内镜下钳夹闭合和不闭合，并按机构和肿瘤大小进行分层。ESD后，所有参与者均进行了计算机断层扫描。PECS定义为视觉模拟量表（VAS）≥30 mm，比基线增加VAS≥20 mm，体温≥37.5°C或大肠ESD后白细胞≥10,000/μL。DP被定义为PECS伴有腔外空气。预先计划的样本量为320例患者，主要终点是PECS / DP的发生率。结果在计划的中期分析中，该试验因独立的数据和安全监控委员会的建议而终止，因为具有优越条件的有条件权力低于预先计划的无效极限。最后，对155例患者进行了分析。非封闭组PECS / DP的发生率为16％（95％置信区间[CI]，8％-23％），封闭组PECS / DP的发生率为24％（95％CI，14％-34％）（P =。 184）。所有DP病例均处于次要标准之内，所有PECS / DP患者均经过保守治疗，无需手术治疗。在非封闭组中，观察到简单的无PECS的管腔周围空气占16％（95％CI，8％-23％），在封闭组中为10％（95％CI，3％-17％）。结论内镜夹闭不能降低大肠ESD后PECS / DP的高发生率。（大学医院医学网络临床试验注册号：UMIN000027031。）。