Technical and clinical success of endoscopic hand-suturing: a European multicenter study

Abstract

Endoscopic closure techniques are essential for management of endoscopic defects and help prevent delayed bleeding and perforation. The SutuArt endoscopic hand-suturing system (EHS) is an innovative method for defect closure, but clinical data remain limited. Methods: In a multicenter European registry study, all procedures using EHS from 14 centers were evaluated. The primary endpoint was technical success, defined as complete defect closure without additional closure techniques. Secondary endpoints were in-hospital clinical success (absence of post-interventional complications); overall defect closure rate (closure achieved with additional devices) and procedure time. Results: Between February 2023 and January 2026, 338 procedures were included. Indications comprised 240 ESD (Endoscopic Submucosal Dissection), 32 EID (Endoscopic Intermuscular Dissection), 41 G-POEM (Gastric Peroral Endoscopic Myotomy), 10 fistulas, 6 EMR (Endoscopic Mucosa Resection), 3 STERs (Submucosal Tunneling Endoscopic Resection), 2 NEWS (Non-exposed Endoscopic Wall inversion Surgery), 1 anastomotic leak, 1 perforation, 1 EFTR (Endoscopic Full Thickness Resection) and 1 endoscopic hemostasis. The median defect size was 35 mm (range 4-155 mm), the median suturing time was 25 minutes (range: 4-120). Technical success was 96.2% (325/338). Overall defect closure rate was 96.7% (327/338). In-hospital clinical success was 97.9% (331/338). Defect size did not predict suturing time in the global size–time model, indicating that procedural complexity was not explained by size alone. Procedure-related adverse events occurred in 5/338 (1.5%), overall AEs were 10/338 (3%). Conclusion: EHS demonstrated high technical and in-hospital clinical success with a low observed short-term adverse event rate. Further studies are needed to assess the performance for complex defects