A novel low‐power pure‐cut hot snare polypectomy for 10–14 mm colorectal adenomas: An ex vivo and a clinical prospective feasibility study (SHARP trial)

Abstract

AbstractBackground and AimHot snare polypectomy using blend or coagulation current is widely used; however, it causes deeper tissue heat injury, leading to adverse events. We hypothesized that hot polypectomy using low‐power pure cut current (PureCut, effect 1 10 W) could reduce deeper tissue heat injury. We conducted animal experiments to evaluate the deeper tissue heat injury and conducted a prospective clinical study to examine its cutting ability.MethodsIn a porcine rectum, hot polypectomy using Blend current (EndoCut, effect 3 40 W) and low‐power pure cut current was performed. The deepest part of heat destruction and thickness of the non‐burned submucosal layer were evaluated histologically. Based on the results, we performed low‐power pure cut current hot polypectomy for 10–14 mm adenoma. The primary endpoint was complete resection defined as one‐piece resection with negative for adenoma in quadrant biopsies from the defect margin.ResultsIn experiments, all low‐power pure‐cut resections were limited within the submucosal layer whereas blend current resections coagulated the muscular layer in 13% (3/23). The remaining submucosal layer was thicker in low‐power pure cut current than in blend current resections. In the clinical study, low‐power pure‐cut hot polypectomy removed all 100 enrolled polyps. For 98 pathologically neoplastic polyps, complete resection was achieved in 84 (85.7%, 95% confidence interval, 77–92%). The lower limit of the 95% confidence interval was not more than 15% below the pre‐defined threshold of 86.6%. No severe adverse events occurred.ConclusionsA novel low‐power pure‐cut hot polypectomy may be feasible for adenoma measuring 10–14 mm. (UMIN000037678).