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

Background: :Endoscopic 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. Objective: To assess the effectiveness of corticosteroid intralesional injection after EBD in preventing stricture recurrence. Design: Single-center prospective, randomized, double-blind, controlled trial. Setting: Tertiary-referral university hospital. Patients: Between November 2005 and January 2009, 29 pediatric patients with stricturing CD were enrolled. Interventions: Enrolled 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 Measurements: Time free of repeat dilation and time free of surgery in the 2 groups. Results: One 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. Limitations: Sample size, participation bias, and short-term follow-up. Conclusion: In pediatric CD with stricture, intralesional CS injection after EBD is an effective strategy for reducing the need both for redilation and surgery. (Gastrointest Enclose 2010;72:1201-8.)