Robot-assisted endoscopic submucosal dissection contributes to efficient and safe learning for novices: Prospective pilot cross-over ex vivo study (with video)

Objectives The lack of effective countertraction to expose the submucosal layer contributes to the technical complication and adverse events in endoscopic submucosal dissection (ESD). We aimed to evaluate the efficacy and safety of a novel endoscopic robot (flexible auxiliary single-arm transluminal endoscopic robot [FASTER]) for ESD learning for novices. Methods This was a prospective, cross-over designed pilot study in ex vivo porcine stomach. Four ESD novices were randomized to either FASTER-assisted ESD first (FC) group or a conventional ESD first (CF) group, performed 40 gastric ESDs using each technique, then crossed over to another technique. The performance and learning curve were compared between the two groups. Results In the first phase, novices in the FC group demonstrated significantly better performance with shorter procedure time (25.6 +/- 7.8 vs. 38.9 +/- 13.4 min; P < 0.001) and submucosal dissection time (13.9 +/- 5.5 vs. 23.1 +/- 11.0 min; P < 0.001), higher direct-vision dissection ratio (84.0 +/- 7.9% vs. 43.5 +/- 20.7%; P < 0.001), and lower muscular injury (2.5 vs. 40.0%; P < 0.001) and task load (4 vs. 5; P < 0.001). Fewer ESDs were required to gain early proficiency in the FC group. When crossed to the second phase, procedure time in the FC group was prolonged but the muscular injury rate did not increase significantly. In total, endoscopists in the FC group tended to have a lower task load (4 vs. 5; P = 0.008) and less muscular injury (10.0 vs. 21.3%; P = 0.05). Conclusion Flexible auxiliary single-arm transluminal endoscopic robot-assisted learning reduces the technical difficulty of ESD for novices and the safety profile can sustain in following conventional ESD. These results indicated that FASTER has potential implications for ESD training in clinical practice.