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.


METHODS
Single-center prospective, randomized, double-blind, controlled trial.


METHODS
Tertiary-referral university hospital.


METHODS
Between November 2005 and January 2009, 29 pediatric patients with stricturing CD were enrolled.


METHODS
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.


METHODS
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.


CONCLUSIONS
Sample size, participation bias, and short-term follow-up.


CONCLUSIONS
In pediatric CD with stricture, intralesional CS injection after EBD is an effective strategy for reducing the need both for redilation and surgery.
Department of Pediatrics, Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy.
Giovanni
G
Di Nardo
Salvatore
S
Oliva
Maurizio
M
Passariello
Nadia
N
Pallotta
Fortunata
F
Civitelli
Simone
S
Frediani
Gianfranco
G
Gualdi
Paolo
P
Gandullia
Saverio
S
Mallardo
Salvatore
S
Cucchiara
D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002404:Catheterization; D002648:Child; D003113:Colonoscopy; D003131:Combined Modality Therapy; D003424:Crohn Disease / Q000628:therapy*; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007077:Ileal Diseases / Q000175:diagnosis / Q000628:therapy*; D015552:Injections, Intralesional; D007415:Intestinal Obstruction / Q000175:diagnosis / Q000628:therapy*; D007579:Jejunal Diseases / Q000175:diagnosis / Q000628:therapy*; D008279:Magnetic Resonance Imaging; D008297:Male; D011446:Prospective Studies; D012008:Recurrence; D014221:Triamcinolone / Q000008:administration & dosage*
D000893:Anti-Inflammatory Agents; D014221:Triamcinolone