Safety and Effectiveness of Oral Budesonide after Endoscopic Balloon Dilation in Patients with Crohn's Disease: A Multicenter Prospective Intervention Study.

Introduction: Budesonide, with its high topical steroidal activity, effectively prevents strictures following esophageal endoscopic treatment. However, its effectiveness in preventing restenosis after endoscopic balloon dilation (EBD) in patients with Crohn's disease (CD) remains unclear. We aimed to evaluate the safety and effectiveness of oral budesonide after EBD in patients with CD. Methods: We conducted a multicenter prospective study of patients with CD who underwent EBD at the University of Osaka and its affiliated hospitals between March 2018 and March 2023 (UMIN000031839, jRCT1051190043). Oral budesonide was administered for 4 weeks after EBD, and patients were followed up for 52 weeks. Safety and effectiveness within 12 and 52 weeks of the procedure were evaluated, with endoscopic evaluation of restenosis at week 52. The stenosis diameter and length were estimated endoscopically and radiographically, respectively. In the historical control study, consecutive patients with CD who underwent EBD between February 2016 and July 2018 were included. The incidence rates of obstructive symptoms and hospitalization at 52 weeks after EBD were retrospectively investigated from the medical records. Results: Overall, 15 patients were analyzed (male, 14 [93.3%]; median age, 44 years [37-49]; disease type, L1, 8 [53.3%]/L3, 7 [46.7%]; stenosis location, jejunum, 1 [6.7%]/ileum, 8 [53.3%]/ileocolonic, 6 [40.0%]; median stenosis diameter, 5 mm [5-6]). No serious complications were observed within 12 or 52 weeks. Twelve (80%) patients showed no symptoms of stenosis within 52 weeks. Of the 14 patients who underwent an endoscopy at week 52, re-EBD was not required in 3 patients (21.4%). The stenosis diameter at week 52 improved significantly compared to the pre-dilation measurements (p = 0.004). Furthermore, the 15 patients treated with budesonide had a significantly lower incidence rates of obstructive symptoms and hospitalization compared to the 19 historical control patients (p = 0.020 and 0.035, respectively). Conclusion: Budesonide administration after EBD can be safely performed in patients with CD and may be effective in preventing restenosis and avoiding hospitalization and intestinal surgery.