Abstract
Objectives: The 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.
Methods: Patients with neoplasms ≤2cm 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.
Results: A 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.
Conclusions: Endoscopic hand suturing may prevent postoperative bleeding in patients undergoing gastric ESD while being treated continuously with ATAs (UMIN000038140).
Trial registration: This study was registered on the University Hospital Medical Information Network before patient recruitment (ID: UMIN000038140).
