Usefulness of endoscopic hand suturing for bleeding prevention following gastric endoscopic submucosal dissection: a multicenter phase II study

Aims Postoperative bleeding accounts for approximately 5% in gastric endoscopic submucosal dissection (ESD) and sometimes leads to a fatal condition. Particularly, patients with continuous administration of antithrombotic agents (ATAs) have a high risk of bleeding. We developed endoscopic hand suturing (EHS), which provides a reliable closure of the mucosal defect following ESD by continuous intraluminal suturing of the tissue using a dedicated flexible needle holder and a commercially available absorbable barbed suture. In this multicenter phase II study, we investigated the effectiveness of EHS for bleeding prevention following gastric ESD in patients at a high risk of delayed bleeding.

Methods We prospectively enrolled patients who had a single neoplasm, measuring 2 cm or less, for the indication of gastric ESD and were recommended to continuously take ATAs perioperatively considering a risk–benefit balance in postoperative bleeding and thromboembolism. Immediately following lesion removal, EHS was applied to the mucosal defect. Soft diet was resumed at least on postoperative day (POD) 1, a scheduled endoscopy was performed to monitor the suture site on POD 3, and the patients were discharged on POD 4 onward. A recommended dose of proton-pump inhibitors or potassium-competitive acid blockers was administered perioperatively. We evaluated the postoperative bleeding rate until 3–4 postoperative weeks as a primary outcome measure and assessed the technical success rate of EHS, closure maintenance rate on POD 3, postoperative subclinical bleeding rate, closure time, and adverse events. We prepared a sample size of 48 patients, considering the postoperative bleeding rate as 10% and 25% for the expected and threshold values, respectively.

Results A total of 49 patients were enrolled, and 43 patients were finally registered as the per-protocol set. They were administered ATAs as follows: antiplatelet agents, 28; anticoagulants, 18; single agent, 37; and dual agents, 6. The postoperative bleeding rate was 7% (3/43 patients; 90% confidence interval [CI], 2.4%–16.7%), wherein the upper limit of CI was below the threshold value (25%), and the postoperative bleeding rate was below the expected value (10%). The technical success rate of EHS, closure maintenance rate on POD 3, and postoperative subclinical bleeding rate were 100%, 83%, and 2%, respectively. The mean closure time was 48 min and the mean of six stitches was required per lesion. In one case, an EHS-related adverse event occurred, wherein the scheduled endoscopy on POD 3 revealed subclinical bleeding from the intentionally created mucosal damage to accurately grasp the needle during the EHS procedure. [1] [2] [3]

Conclusions The results demonstrated that EHS was useful for preventing postoperative bleeding in gastric ESD for patients with continuous ATA administration. To demonstrate the preventability of this technique for postoperative bleeding in high-risk patients, further confirmatory studies are needed (UMIN000038140).

Publication History

Article published online:
15 April 2024

• References

• 1 Goto O, Sasaki M, Ishii H. et al. A new endoscopic closure method for gastric mucosal defects: feasibility of endoscopic hand suturing in an ex vivo porcine model (with video). Endosc Int Open 2014; 2: E111-6
• 2 Akimoto T, Goto O, Nishizawa T. et al. Endoscopic closure after intraluminal surgery. Dig Endosc 2017; 29: 547-58
• 3 Goto O, Sasaki M, Akimoto T. et al. Endoscopic hand suturing for defect closure after gastric ESD: a pilot study in animals and in humans. Endoscopy 2017; 49: 792-7