Feasibility of pure EFTR using an innovative new endoscopic suturing device: the Double-arm-bar Suturing System (with video)

Abstract

Endoscopic full-thickness resection (EFTR) requires a reliable full-thickness suturing device and an endoscopic counter-traction device to prevent the collapse of the digestive tract. The present study aimed to assess the reliability of newly developed flexible endoscopy suturing devices and the feasibility of pure EFTR. A total of 30 EFTRs were performed and allocated to three groups (N=10 for each group). The full-thickness sutures were placed using over-the-scope clips (OTSCs), hand-sewn sutures, or the Double-arm-bar Suturing System (DBSS). Air leak tests were conducted in the three groups. The times required for the placement of one OTSC suture and single-stitch simple interrupted sutures (hand-sewn and DBSS sutures, respectively) were also compared. All 30 full-thickness sutures were completely and successfully placed. Regarding the air leak tests, the Mann-Whitney U test showed significant differences between OTSC and hand-sewn sutures (p=0.003). There was also a significant difference between OTSC and DBSS sutures (p=0.023). There was no significant difference between hand-sewn and DBSS sutures (p=0.542). A significant difference was found in the suture time for single-stitch simple interrupted sutures among the OTSC, hand-sewn, and DBSS sutures. The Mann-Whitney U test revealed a significant difference between OTSC and hand-sewn sutures (p=0.0001). There was no significant difference between OTSC and DBSS sutures (p=0.533), while a significant difference was found between hand-sewn and DBSS sutures (p=0.0001). Pure EFTR is feasible if the mechanical counter traction system is used to expand a small operative field and DBSS is used to make full-thickness sutures. The high safety of full-thickness resection and full-thickness suturing allows for clinical applications of this method.