Prospective, randomized comparison of a prototype endoscope with deflecting working channels versus a conventional double-channel endoscope for rectal endoscopic submucosal dissection in an established experimental simulation model (with video)

Abstract

Background: A prototype endoscope was designed to improve visualization and dissection of tissue with the use of 2 working channels with different deflections. Objective: To evaluate the efficacy and operability of a prototype endoscope in comparison with a conventional double-channel endoscope for rectal endoscopic submucosal dissection (ESD). Design: Randomized, prospective, controlled, ex vivo study. Setting: Academic medical center. Methods: A total of 80 standardized artificial lesions measuring 3 x 3 cm were created approximately 5 cm from the anal verge in fresh ex vivo porcine colorectal specimens. Two endoscopists each completed 20 cases with the prototype endoscope and 20 cases with the conventional endoscope. Main Outcome Measurements: An independent observer recorded procedure time, specimen size, en bloc resection, and perforation rate. Results: For the ESD novice, the mean submucosal dissection time (10.5 +/- 3.8 vs 14.9 +/- 7.3 minutes; P = .024) and total procedure time (18.1 +/- 5.2 vs 23.6 +/- 8.2 minutes; P = .015) were significantly shorter in the prototype group in comparison with the conventional group. For the ESD expert, there was no significant difference between the mean circumferential resection, submucosal dissection, and total procedure time (prototype group 14.2 +/- 6.0 minutes, conventional group 14.2 +/- 8.8 minutes; P = .992). The overall perforation and en bloc resection rates were not significantly different between groups. Limitations: Ex vivo study. Conclusion: In this ex vivo prospective comparison study, there was a technical advantage for the ESD novice with the prototype endoscope that resulted in a shorter procedure time, which was not observed for cases performed by the ESD expert.