A pilot study of intrastricture steroid versus placebo injection after balloon dilatation of Crohn's strictures.

BACKGROUND & AIMS: Restricturing after ileocolonic resection for Crohn's disease is common. Colonoscopic balloon dilatation is effective but repeated dilatations often are required. Intrastricture steroid injection after balloon dilatation has been reported to reduce the need for repeat dilatation in retrospective series, but no randomized data are available. METHODS: We performed a pilot study comparing local quadrantic injection of triamcinolone (40 mg total dose) after endoscopic balloon dilatation of Crohn's ileocolonic anastomotic strictures vs saline placebo. The primary end point was time to redilatation or surgery. Patients were followed up for 52 weeks. RESULTS: Thirteen patients were randomized, 7 to steroid and 6 to placebo. Groups were well matched for baseline and dilatation characteristics. In the intention-to-treat analysis, 1 of 6 patients in the placebo group and 5 of 7 patients in the steroid group needed redilatation (log rank test P = .06; Cox regression P = .10; hazard ratio, 6.1; 95% confidence interval, 0.7-53.0). In the per-protocol analysis the differences were more significant (log rank test P = .03; Cox regression P = .07; hazard ratio, 7.7; 95% confidence interval, 0.9-67.9). CONCLUSIONS: A single treatment of intrastricture triamcinolone injection did not reduce the time to redilatation after balloon dilatation of Crohn's ileocolonic anastomotic strictures and there was a trend toward a worse outcome. The use of this technique in clinical practice should be considered carefully until more data are available.