NCT06036680

Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

Long-term Follow-up ProtDilat Study; Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Self-expandable Metal Stent vs. Endoscopic Balloon Dilatation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications. The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis \> 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros). Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial. The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis \< 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.

Conditions

• Crohn Disease
• Stenosis

Timeline

• Start date: 2022-12-19
• Primary completion: 2023-09-15
• Completion: 2023-12-31
• First posted: 2023-09-14
• Last updated: 2023-09-14

Locations

1 site across 1 country: Spain