A Pilot Study Investigating the Safety and Feasibility of Endoscopic Dilation Using a Radial Incision and Cutting Technique for Benign Strictures of the Small Intestine: A Study Protocol

Abstract

BackgroundSmall benign intestinal stenosis is usually treated by endoscopic balloon dilation (EBD) or surgery. Although, EBD and surgery are able to resolve the stenosis in most case, they are associated with several problems such as insufficient dilation and surgical stress, respectively. On the contrary, a novel approach called radial incision and cutting (RIC) is reported to have several benefits when compared to EBD and surgery. We can currently adopt RIC only for the strictures in the colon or terminal ileum and not for those stenotic lesions present further in the small intestine where balloon-assisted endoscopy is utilized, because long-type electric knife is currently not approved for use in Japan. We will herein conduct a pilot study to investigate the safety and feasibility of RIC for treating the benign stenoses of the small intestine using the long-type electric knife.Methods This will be a single-center, single-arm, interventional trial. The major criteria for inclusion will be age ranging from 20 to 80 years and the presence of benign stenosis in the small intestine. We will perform RIC in 10 participants. The primary outcome is the safety of this procedure, which will be assessed by measuring the frequency of adverse events of special interest. The secondary outcomes will be technical success rate, improvement in subjective symptoms, procedure time, and duration of hospitalization.DiscussionThis pilot study will provide useful information that will aid in adopting RIC for treating the benign strictures present in the small intestine. Trial registration jRCT Identifier, jRCTs022200040. Registered on 1 March 2021.URL: https://jrct.niph.go.jp/re/reports/detail/11533