A pilot human study on newly designed closure clips in endoscopic closure of giant gastrointestinal perforation using a continuous closing method.

Background: A large gastrointestinal perforation is a serious and even life-threatening clinical condition. Current endoscopic techniques for closing large gastrointestinal perforation have limitations. Building upon our recent findings in a porcine model, this pilot human study aimed to evaluate the safety, feasibility, and effectiveness of a novel endoscopic technique using newly designed closure clips for closure of giant gastrointestinal perforation.

Methods: A total of 18 patients who underwent endoscopic submucosal dissection (ESD) and developed giant gastrointestinal perforation > 2 cm in diameter were enrolled in this study. The newly designed closure clips, consisting of a sewing clip and knotter, were applied in endoscopic closure of the gastrointestinal perforations using a continuous suturing method. The safety, feasibility, and effectiveness were subsequently assessed in these patients.

Results: Endoscopic closure of the giant perforation was achieved in all patients. In evaluation of safety and effectiveness of this technique with the new closure clips and the continuous suturing method, no obvious intraoperative complications (e.g., bleeding, abdominal infection) occurred in the studied patients. Furthermore, on 1-month follow-up gastric endoscopy, all the patients showed complete closure of the gastrointestinal perforations, and no clinical signs of specific abnormalities or symptoms were observed.

Conclusion: This novel technique has been shown to be safe, effective, and feasible for the treatment of giant gastrointestinal perforation.