Endoscopic hand suturing has the potential to reduce bleeding after gastric endoscopic submucosal dissection in patients on antithrombotic agents: Multicenter phase II study

被引：0

作者：

Goto, Osamu ^{[1
,3
]}

Morita, Yoshinori ^{[6
]}

Takayama, Hiroshi ^{[6
]}

Hirasawa, Kingo ^{[7
]}

Sato, Chiko ^{[7
]}

Oyama, Tsuneo ^{[8
]}

Takahashi, Akiko ^{[8
]}

Abe, Seiichiro ^{[5
]}

Saito, Yutaka ^{[5
]}

Ono, Hiroyuki ^{[9
]}

Kawata, Noboru ^{[9
]}

Otsuka, Toshiaki ^{[2
,4
]}

Iwakiri, Katsuhiko ^{[1
]}

机构：

[1] Nippon Med Sch, Grad Sch Med, Dept Gastroenterol, 1-1-5 Sendagi,Bunkyo Ku, Tokyo 1138603, Japan

[2] Nippon Med Sch, Grad Sch Med, Dept Hyg & Publ Hlth, Tokyo, Japan

[3] Nippon Med Coll Hosp, Endoscopy Ctr, Tokyo, Japan

[4] Nippon Med Coll Hosp, Ctr Clin Res, Tokyo, Japan

[5] Natl Canc Ctr, Endoscopy Div, Tokyo, Japan

[6] Kobe Univ, Int Clin Canc Res Ctr, Dept Gastroenterol, Kobe, Hyogo, Japan

[7] Yokohama City Univ, Div Endoscopy, Med Ctr, Kanagawa, Japan

[8] Saku Cent Hosp Adv Care Ctr, Dept Endoscopy, Nagano, Japan

[9] Shizuoka Canc Ctr, Div Endoscopy, Shizuoka, Japan

来源：

DIGESTIVE ENDOSCOPY | 2025年 / 37卷 / 03期

关键词：

antithrombotic agent; endoscopic hand suturing; endoscopic submucosal dissection; postoperative bleeding; MUCOSAL RESECTION; RISK-FACTOR; CLOSURE; WARFARIN; DEFECTS; THERAPY; MODEL;

D O I：

10.1111/den.14911

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

ObjectivesThe risk of postoperative bleeding is high after gastric endoscopic submucosal dissection (ESD) in patients continuously treated with antithrombotic agents (ATAs). The effectiveness of endoscopic hand suturing (EHS) on bleeding after gastric ESD was investigated in patients at high risk of delayed bleeding.MethodsPatients with neoplasms <= 2 cm who underwent gastric ESD and continued to receive perioperative ATAs were enrolled in this multicenter phase II study. The mucosal defect was closed with EHS after removing the lesion. Postoperative bleeding rate was assessed for 3-4 postoperative weeks as a primary outcome measure. The technical success of EHS and adverse events were also assessed. Based on expected and threshold postoperative bleeding rates of 10% and 25%, respectively, we aimed to include 48 patients in the study.ResultsA total of 49 patients were enrolled in the study, and 43 patients were finally registered as the per-protocol set. The postoperative bleeding rate was 7.0% (3/43 patients; the upper limit of one-sided 95% confidence interval [CI], 17.1% and 97.5% CI, 19.1%). The upper limits of the CI were below the threshold value (25%), and the postoperative bleeding rate was below the expected value (10%). The technical EHS success rate, closure maintenance rate on postoperative day 3, and postoperative subclinical bleeding rate were 100%, 83%, and 2%, respectively. No severe adverse events related to EHS were observed.ConclusionsEndoscopic hand suturing may prevent postoperative bleeding in patients undergoing gastric ESD while being treated continuously with ATAs (UMIN000038140).

引用

页码：266 / 274

页数：9

共 37 条

[1] Endoscopic hand suturing for mucosal defect closure after gastric endoscopic submucosal dissection may reduce the risk of postoperative bleeding in patients receiving antithrombotic therapy [J].