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

ABSTRACT

Introduction The development of EndoMaster EASE system aims to enhance safety and efficacy of colonic ESD through two flexible robotic arms for tissue retraction and dissection. This is the first clinical trial to evaluate the performance of colorectal ESD using EndoMaster. Method Patients with early mucosal colorectal neoplasia not feasible for en-bloc resection with snare-based techniques were recruited. The EndoMaster EASE robotic system consisted of an independently designed flexible robotic platform with 2 robotic arms. The primary outcome was complete resection rate using EndoMaster. Secondary outcomes included operating time, hospital stay, procedure-related complications and oncological outcomes. Results From May 2020 to Jan 2022, 43 patients received robotic ESD with median age of 66 years (40-83). The mean robotic dissection time was 62.0 ± 45.1 minutes. All procedures except six were completed using EndoMaster with technical success rate of 86.1% (37/43). The en-bloc resection rate among cases with technical success was 94.6% (35/37) while the complete resection rate was 83.8% (31/37). The median size of specimen was 35mm (15-90mm). The mean hospital stay was 2.6 ± 1.2 days and there was one delayed bleeding 4 days after ESD which was controlled by endoscopy. One patient sustained perforation during procedure which was completely closed using clips without sequelae. 2 patients required salvage surgery due to deep margin involvement by adenocarcinoma in histopathology. Conclusion This first clinical trial confirmed the safety and efficacy of performing colorectal ESD using EndoMaster EASE robotic system (Clinicaltrial.gov NCT04196062).