Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4-9mm polyps.

Abstract

Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps < 10mm. Use of viscous submucosal agents has not been previously evaluated in CSP. We investigate the potential role of EverLift™ (GI Supply, Pennsylvania) in CSP. The study is a single-center prospective randomized non-inferiority clinical trial evaluating CSP of non-pedunculated 4-9mm polyps, with or without submucosal injection of EverLift™. Patients 18-80years of age presenting for colonoscopy were recruited. Eligible polyps underwent block randomization to CSP with or without EverLift™. Following CSP, two biopsies were performed at the CSP site margin. The primary non-inferiority outcome was complete resection rate, defined by absence of residual polyp in the margin biopsies (non-inferiority margin -10%). A total of 291 eligible polyps underwent CSP, with 142 removed using EverLift™. There was similar polyp size and distribution of pathology between the two groups. Overall, there was a low rate of positive margins with (1.4%) or without submucosal injection (2.8%), with no significant difference in complete resection (difference 1.28%, 95% CI: -2.66 to 5.42%), demonstrating non-inferiority of EverLift™ injection. Use of EverLift™ significantly increased CSP time (109.8 vs 38.8s, p < 0.0001) and frequency of use of hemostatic clips (13.4 vs 3.6%, p = 0.002). Submucosal injection of EverLift™ was non-inferior to CSP of 4-9mm polyps without injection and increased time for resection as well as use of hemostatic clips to control acute bleeding. Our results suggest that polypectomy of 4-9mm polyps can be safely performed without submucosal injection of EverLift™.