Feasibility of O-ring and Over-The-Scope Clip closure after gastric endoscopic full-thickness resection: From animal experience to clinical introduction

Aims: In endoscopic full-thickness resection (EFTR), reliable closure remains controversial. We developed endoscopic ligation with O-ring closure (E-LOC)-assisted Over-The-Scope Clip (OTSC) closure (EL-OTSC) in ex vivo. This study aimed to evaluate the feasibility in animal and clinical settings.
Methods: EFTR mainly involved clip-line traction. EL-OTSC comprised E-LOC for centered defect to diminish insufflation leakage, followed by TwinGrasper-OTSC closure aiming seromuscular inverted closure. Animal study: These procedures were performed for 2-cm virtual lesions in six dogs. Clinical study: Patients who underwent EFTR for gastric GISTs less than 3 cm were prospectively enrolled (Ethical Approval No.350). After completion of EFTR and EL-OTSC under single-port laparoscopy, laparoscopic seromuscular suture was finally added to ensure the safety. The primary endpoint was presence of leakage after EL-OTSC.
Results: Complete resection and successful closure were achieved in all dogs. In clinical study, 4 cases were enrolled. No leakage occurred in all cases. The mean procedure time of EFTR, and EL-OTSC was 75 and 54 minutes, respectively. Histological examination confirmed curative resection of GISTs in all cases.
Conclusions: A newly-developed EL-OTSC in animal experimental study was also feasible for gastric full-thickness closure in clinical setting.