BACKGROUND AND AIMS Endoscopic hand-suturing (EHS) provides secure intraluminal mucosal closure and should decrease the risk of adverse events after gastric endoscopic submucosal dissection (ESD). We prospectively investigated the feasibility and safety of EHS after gastric ESD, particularly for preventing post-ESD bleeding. METHODS Patients scheduled for gastric ESD at 3 institutions were prospectively recruited. Just after ESD, the mucosal defect was closed by EHS. The primary outcome was endoscopic assessment of adequately sustained closure of the defect on postoperative day 3. Endoscopy was performed to assess maintenance of the closure for the primary outcome. During postoperative weeks 3 to 4, patients were interviewed as outpatients about any occurrence of delayed bleeding. RESULTS Data from 30 patients (15 each who did or did not take antithrombotic agents) were analyzed. Mucosal closure by EHS was completed in 29 of 30 cases (97%) and was well maintained on postoperative day 3 in 25 cases (84%). Emergency endoscopy was required for major postoperative bleeding in 3 cases (10%), including 1 in which suturing had been incomplete. Excluding 1 patient with a remnant stomach, the other 24 with sustained closure had no bleeding, regardless of whether they did or did not take antithrombotic agents (0/11 and 0/13, respectively). No serious adverse events occurred during EHS. CONCLUSIONS Results show that EHS is feasible and safe with favorable outcomes. Provided that mucosal suturing is successfully completed and sustained, post-ESD bleeding can be decreased even in patients undergoing antithrombotic therapy. (Clinical trial registration number: UMIN 000033988.).

中文翻译：

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内镜下手工缝合是可行，安全的，并且可以减少胃镜下黏膜下剥离后的出血风险：一项多中心先导研究（带视频）。

背景与目的内镜手工缝合（EHS）可提供安全的腔内粘膜闭合，并应减少胃内镜下粘膜下剥离术（ESD）后发生不良事件的风险。我们前瞻性研究了胃ESD后EHS的可行性和安全性，特别是用于预防ESD后出血。方法前瞻性招募了3家机构的胃ESD患者。静电释放后，粘膜缺损被EHS封闭。主要结果是在术后第3天进行内窥镜评估，以充分持续闭合缺损。进行内窥镜检查以评估维持闭合的主要结果。术后3至4周内，以门诊病人的身份就任何延迟出血发生进行了访谈。结果分析了30例患者的数据（每例15例未使用抗栓剂）。30例中有29例（97％）完成了通过EHS进行的粘膜闭合，25例（84％）在术后第3天保持良好。重大术后出血需要紧急内镜检查3例（10％），其中1例缝合不完全。除1名残存胃部的患者外，其余24名持续闭合的患者均未出血，无论他们是否服用抗血栓药（分别为0/11和0/13）。在EHS期间没有发生严重的不良事件。结论结果表明，EHS是可行和安全的，并具有良好的效果。只要成功完成并持续进行粘膜缝合，即使在接受抗血栓治疗的患者中，ESD后的出血也可以减少。