Intralesional steroid injection after endoscopic balloon dilation in pediatric Crohn's disease with stricture: a prospective, randomized, double-blind, controlled trial

BackgroundEndoscopic balloon dilation (EBD) is an attractive conservative therapy for Crohn's disease (CD) with stricture; however, its long-term efficacy has been questioned because many patients require more dilations or postdilation surgery. Most reports are retrospective, and no pediatric data are available.ObjectiveTo assess the effectiveness of corticosteroid intralesional injection after EBD in preventing stricture recurrence.DesignSingle-center prospective, randomized, double-blind, controlled trial.SettingTertiary-referral university hospital.PatientsBetween November 2005 and January 2009, 29 pediatric patients with stricturing CD were enrolled.InterventionsEnrolled patients were randomized to receive intrastricture injection of corticosteroid (CS) (n = 15) or placebo (n = 14) after EBD. Patients were followed clinically via small intestine contrast US and intestinal magnetic resonance imaging at 1, 3, 6, and 12 months; all underwent colonoscopy 12 months after dilation.Main Outcome MeasurementsTime free of repeat dilation and time free of surgery in the 2 groups.ResultsOne of the 15 patients receiving CS required redilation, whereas the latter was needed in 5 of the 14 placebo patients; surgery was needed in 4 of the placebo patients, but in none of those receiving CS. The 2 groups statistically differed in the time free of redilation (P = .04) as well as for time free of surgery after EBD (P = .02), which were worse in the placebo group compared with the CS group. There were no significant differences in baseline demographics between the 2 groups.LimitationsSample size, participation bias, and short-term follow-up.ConclusionIn pediatric CD with stricture, intralesional CS injection after EBD is an effective strategy for reducing the need both for redilation and surgery.