Safety and efficacy of traction robot-assisted endoscopic submucosal dissection for early gastric cancer: a randomized pilot trial

摘要

Background: Several animal studies have demonstrated the safety and efficacy of a flexible auxiliary single-arm transluminal endoscopic robot in assisting gastric endoscopic submucosal dissection (ESD). This study aimed to assess its performance for the first time in a real clinical setting. Methods: We conducted this prospective, single-blind, pilot randomized controlled trial at a tertiary teaching hospital. Patients with gastric high grade intraepithelial neoplasia or intramucosal carcinoma were randomized to either robot-assisted or conventional ESD. The primary outcome was procedure time. Secondary outcomes included R0 and en bloc resection rates, dissection time, and procedure-related complications. Results: 48 patients underwent successful procedures without perforation. Despite no significant difference in procedure time between robot-assisted and conventional ESD (58.21 vs. 39.21 minutes; P = 0.08), a learning curve effect was observed, with shorter procedure times in the last 12 cases with robot assistance compared with the last 12 conventional ESDs (56.82 vs. 63.10 minutes; P = 0.71). Muscular injuries were significantly reduced with robot assistance (1.50 vs. 9.00; P < 0.001). No significant difference was found in R0 (95.8% vs. 91.7%; P > 0.99) and en bloc (100% vs. 95.8%; P > 0.99) resection rates between robot-assisted and conventional ESD, respectively. Conclusions: This preliminary evidence supports the feasibility of robot-assisted gastric ESD.