Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study

OBJECTIVE: Fibrotic strictures in the gastrointestinal tract are frequent in Crohn’s disease. Endoscopic dilation is a standard treatment. However, recurrence is common after dilation and there are complications such as bleeding or perforation. Endoscopic treatment using self-expandable metal stents has shown diverging results. The aim of this study was to evaluate the outcome of endoscopic treatment with a self-expandable stent in ileocecal Crohn’s disease. DESIGN/METHOD: Patients with Crohn’s disease and a symptomatic ileocecal stricture were eligible for prospective, consecutive inclusion in a single-centre setting. Patients were randomised to treatment with either 18 mm balloon dilatation (Group(DIL)) or stenting (Group(STENT)) using a 20 mm diameter, partially covered Hanarostent NCN. Patients were followed for a minimum of 24 months postendoscopy. Outcomes were technical success, adverse events and clinical success (defined as no need for repeated interventions). RESULTS: Thirteen patients (Group(DIL) n=6; Group(STENT)=7) were included with twelve patients (Group(DIL) n=5; Group(STENT)=7) being eligible for complete follow-up. Technical success was achieved in all cases. Adverse events were border-line significantly more common in the Group(STENT): 4/7 (57%) (pain: n=3; pain and rectal bleeding: n=1) compared with the Group(DIL): 0/5 (0%), p=0.08, which resulted in preterm termination of the study. The clinical success rate was Group(STENT): 6/7 (86%) vs Group(DIL): 1/5 (20%), p=0.07. CONCLUSION: Patients with strictures related to Crohn’s disease may benefit from treatment with self-expandable metal stents rather than dilatation. However, there seems to be an increased risk for patient pain after stenting, which has to be considered and handled. TRAIL REGISTRATION NUMBER: The study was registered at Clinical Trials (NCT04718493).