A Pooled Analysis of Efficacy, Safety, and Long-term Outcome of Endoscopic Balloon Dilation Therapy for Patients with Stricturing Crohn's Disease

Background: Endoscopic balloon dilation (EBD) is widely used to manage Crohn's disease-associated strictures. However, most studies of the safety and efficacy are small and heterogenous. We performed a combined analysis of published studies and evaluated 676 comprehensive individual participant data sets to determine the overall effects of EBD. Methods: Citations from the Embase, MEDLINE, and the Cochrane library from 1991 through 2013 were systematically reviewed, and references of cited articles were assessed for relevant publications. We collected data from studies including >= 15 patients and additionally generated a unique individual patient database containing 676 individual data sets derived from 12 studies. Technical feasibility, short-term and long-term efficacies, and safety were evaluated. Results: In 1463 patients with Crohn's disease who underwent 3213 EBD procedures, 98.6% of strictures were ileal and 62% anastomotic. The technical success rate of the EBDs was 89.1% with a clinical efficacy of 80.8%. Complications occurred in 2.8% per procedure. After 24 months of follow-up, 73.5% of subjects underwent redilation and 42.9% surgical resection. In a multivariate analysis of 676 individual patients, a stricture length of <= 5 cm was associated with a surgery-free outcome; every 1 cm increase of stricture length increased the hazard of need for surgery by 8% (P = 0.008). Inflammation did not affect outcomes or rate of complications. Conclusions: Based on a systematic literature review and analysis of data sets from 676 patients, EBD has a high rate of short-term technical and clinical efficacies, with substantial long-term efficacy and acceptable rates of complication.