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

Abstract

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 (GroupDIL) or stenting (GroupSTENT) 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 (GroupDIL n=6; GroupSTENT=7) were included with twelve patients (GroupDIL n=5; GroupSTENT=7) being eligible for complete follow-up. Technical success was achieved in all cases. Adverse events were border-line significantly more common in the GroupSTENT: 4/7 (57%) (pain: n=3; pain and rectal bleeding: n=1) compared with the GroupDIL: 0/5 (0%), p=0.08, which resulted in preterm termination of the study. The clinical success rate was GroupSTENT: 6/7 (86%) vs GroupDIL: 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).