Self-expanding metal stents versus endoscopic balloon dilation for the treatment of strictures in Crohn’s disease (ProtDilat study): open-label, multicenter, randomized trial

This multicentre, open and randomized trial was carried out in 19 tertiary and secondary hospitals in Spain. Patients with Crohn’s disease with obstructive symptoms and predominantly fibrous strictures less than 10 cm in length were eligible for inclusion. We excluded patients with stenosis treated by SEMS or EBD in the previous year and stenosis not accessible to the colonoscope. Patients were randomized (1:1) to receive either EBD (EBD group) or FCSEMS (FCSEMS group) using a block numerical randomization system (block size of four) . In the EBD group, dilation was performed with a Boston Scientific CRE pneumatic balloon (Marlborough, MA, USA) with the diameter set at the discretion of the endoscopist; a maximum of two dilation sessions were allowed with a minimum interval of 15 to 30 days between them. In the FCSEMS group, a metal stent entirely covered with Taewoong (Gimpo-si, South Korea) of 20 mm in diameter was placed; the length of the stent was fixed at the discretion of the endoscopist. The primary endpoint was to assess the efficacy of endoscopic treatment, defined by the proportion of patients without new therapeutic intervention (EBD, FCSEMS or surgery) due to symptomatic recurrence at 1 year of follow-up. Patients were analyzed on an intention-to-treat basis. Adverse events were recorded for all patients; events were considered to be associated with the procedure when a causal association was possible, probable or certain. This trial is registered with ClinicalTrials.gov, NCT02395354.