Original article—alimentary tract
A Pilot Study of Intrastricture Steroid Versus Placebo Injection After Balloon Dilatation of Crohn’s Strictures

Presented orally at the British Society of Gastroenterology conference, Birmingham, March 20–23, 2006 (Gut 2006;55(Suppl II):A18); and as a poster presentation at Digestive Disease Week, Los Angeles, May 20–25, 2006 (Gastrointest Endosc 2006;63:AB207).
https://doi.org/10.1016/j.cgh.2007.04.013Get rights and content

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.

Section snippets

Methods

Patients aged 18 years or older presenting to St. Mark’s Hospital who had symptomatic Crohn’s strictures, less than 5 cm in length as assessed by barium studies, and thought to be suitable for colonoscopic dilatation (ie, endoscopically accessible), were invited to participate in this study. Patients also had to have failed medical therapy with steroids and aminosalicylates. All patients gave written informed consent and the study was approved by the local research ethics committee. Recruitment

Results

Thirteen patients were recruited, 7 were randomized to the steroid group and 6 were randomized to the placebo group. All patients in the steroid group had follow-up evaluation until week 52; 4 of 6 patients in the placebo group had follow-up evaluation until week 52. Data for the 2 patients who did not complete the follow-up evaluation were available until days 113 and 160 postdilatation, and they were censored at these points. Further follow-up data for these patients to week 52 subsequently

Discussion

In this pilot study, quadrantic intrastricture injection of triamcinolone 40 mg after balloon dilatation of Crohn’s ileocolonic anastomotic strictures did not improve time to redilatation or surgery. In fact, there was an unexpected trend for the need for earlier redilatation with the use of triamcinolone in the intention-to-treat analysis, which was statistically significant in the per-protocol analysis.

This patient group was very similar in terms of age, body mass index, Crohn’s duration, and

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