Prospective single-arm trial on feasibility and safety of an endoscopic robotic system for colonic endoscopic submucosal dissection

Abstract

Background The development of the EndoMaster "Endo luminal Access Surgical Efficacy"(EASE) system aims to enhance the safety and efficacy of colonic endoscopic sub mucosal dissection (ESD) through two flexible robotic arms. This is the first clinical trial to evaluate the perform ance of colorectal ESD using EndoMaster. Method Patients with early mucosal colorectal neoplasia that was not suitable for en bloc resection with snare-based techniques were recruited. The EndoMaster EASE robotic system consisted of an independently designed flexible ro botic platform with tworobotic arms. Theprimaryoutcome wasthecompleteresection rateusingEndoMaster. Second ary outcomesincluded operatingtime, hospital stay, proce dure-related complications, and oncologic outcomes. Results 43 patients underwent robotic ESD, with a median robotic dissection time of 49 minutes. The technical suc cess rate was 86.0%, while en bloc resection rate among cases with technical success was 94.6%. The complete re section rate was 83.8% and the median size of specimen was 35mm (range 15-90mm). The median hospital stay was 2 (range 1-7) days and there was one delayed bleed after 4 days, which was controlled endoscopically. One pa tient sustained perforation during the procedure, which was completely closed using clips without sequelae. Two patients were treated by salvage surgery. Conclusion This first clinical trial confirmed the safety and efficacy of performing colorectal ESD using the EndoMaster EASE robotic system.