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

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Fund

Endoscopic balloon dilation (EBD) is the established endoscopic treatment for short strictures in Crohn’s disease. Fully covered self-expanding metal stents (FCSEMS) have been used for the endoscopic treatment of patients for whom EBD has failed. Our objective was to determine the efficacy and safety of the two endoscopic treatments in patients with Crohn’s disease with stenosis and to compare the average cost of the two treatments.

Methods

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 numerical block 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.

Results

From August 28, 2013 to October 9, 2017, we assessed the eligibility of 99 patients, of whom 19 (19%) patients were excluded. Thus, 80 (81%) patients were randomly assigned to treatment: 39 (49%) patients in the FCSEMS group and 41 (51%) patients in the EBD group. 33 (80%) of the 41 patients in the EBD group and 20 (51%) of the 39 patients in the FCSEMS group were free of a new therapeutic intervention at 1 year (odds ratio [OR]
3 9 [95% CI 1·4–10·6]; p=0 0061). Two (3%) of 80 patients experienced serious adverse events (one [2%] patient from the EBD group and a [3%] patient in the FCSEMS group); both patients had perforations.

Interpretation

EBD is more effective than FCSEMS for Crohn’s disease strictures, with a good safety profile for both treatments.

Funding

Spanish National Institute of Health, Foundation of the Spanish Society of Digestive Endoscopy, Catalan Society of Gastroenterology and Taweoong.

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