Pilot Study Investigating the Safety and Efficacy of Metallic Stent Insertion for Ileocolonic Anastomotic Strictures Related to Crohn's Disease: A Study Protocol.

INTRODUCTION: Lower gastrointestinal tract stenoses are commonly treated with surgery or endoscopic balloon dilation. We conducted a clinical trial to investigate a novel endoscopic treatment called radial incision and cutting (RIC). Although RIC has demonstrated a high technical success rate and has been shown to improve subjective symptoms, the relatively high rate of delayed bleeding in cases of ileocolonic anastomotic strictures due to Crohn's disease (CD) can be problematic. Herein, we report the design of a prospective, single-center, single-arm, exploratory pilot study to evaluate safety and feasibility of self-expandable metallic stent (SEMS) placement as an alternative dilation strategy for ileocolonic anastomotic strictures in CD, particularly in patients in whom delayed bleeding after RIC has been a clinical concern. METHODS: The major inclusion criteria include age 18-80 years, ileocolonic anastomotic strictures after surgery for CD, and a history of endoscopic balloon dilation or RIC for such strictures. We will employ a SEMS designed for malignant biliary stenosis and conduct SEMS placement in five participants. The primary outcome is the safety of SEMS placement, assessed by determining the frequency of adverse events of special interest, including delayed bleeding and perforation. The secondary outcomes include the technical success rate of SEMS placement, procedure duration, improvement in subjective symptoms, SEMS migration rate, success rate of SEMS removal 1 week after placement, and duration of hospitalization. Subjective symptom improvement is evaluated using the visual analog scale, and long-term results are analyzed using descriptive statistics, Student's t-test, and Kaplan-Meier curves. CONCLUSION: This exploratory study provides useful information regarding the safety of SEMS placement for ileocolonic anastomotic strictures due to CD, which may contribute to further investigation.