Novel single-operator through-the-scope traction device for endoscopic submucosal dissection: Outcomes of a multicenter randomized pilot ex-vivo study in trainees with limited endoscopic submucosal dissection experience (with video)

Objectives: Endoscopic submucosal dissection is a technically demanding procedure. The pilot study aimed to prospectively evaluate the efficacy and safety of a novel single-operator through-the-scope dynamic traction device among trainees with limited endoscopic submucosal dissection (ESD) experience. Methods: Randomized, controlled, pilot study comparing traction-assisted ESD (T-ESD) versus conventional ESD (C-ESD) in an ex-vivo porcine stomach model. Trainees were randomized to group 1 (T-ESD followed by C-ESD) and group 2 (C-ESD followed by T-ESD). Lesions were created on the gravity-dependent area of the stomachs. The primary outcome was submucosal dissection speed. Secondary outcomes included differences in en-bloc resection, adverse events, and workload, assessed by the National Aeronautical and Space Administration Task Load Index (NASA-TLX). Results: Five trainees performed two T-ESD and two C-ESD each, for a total of 20 procedures. Submucosal dissection speed was significantly faster in the T-ESD group compared to the C-ESD group (43.32 22.61 vs. 24.19 +/- 15.86 mm(2)/min; p = 0.042). En-bloc resection was achieved in 60% with T-ESD and 70% with C-ESD (p = 1.00). The muscle injury rate was higher in the C-ESD group (50% vs. 10%; p = 0.21) with 1 perforation reported with C-ESD and none with T-ESD. NASA-TLX physical demand was lower with T-ESD compared to C-ESD (4.5 +/- 2.17 vs. 6.9 +/- 2.50; p = 0.03). Conclusion: T-ESD resulted in faster submucosal dissection and less physical demand when compared to C-ESD, as performed by trainees in an ex-vivo gravity-dependent model. Future studies are needed to assess its role in human ESD cases.