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

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

Sponsors & Collaborators

• Clínica Girona

  collaborator UNKNOWN

• Complejo Hospitalario Universitario de Vigo

  collaborator OTHER

• Consorcio Hospital Universitario Clinico de Valencia

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Comarcal de Inca

  collaborator OTHER

• Hospital de Terrassa

  collaborator OTHER

• Hospital General la Mancha-Centro

  collaborator UNKNOWN

• Parc Taulí Hospital Universitari

  collaborator OTHER

• Hospital Universitario Ramón y Cajal

  collaborator UNKNOWN

• Hospital Universitario Reina Sofía

  collaborator UNKNOWN

• Hospital Universitari de Bellvitge

  collaborator OTHER

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Universitari Arnau de Vilanova

  collaborator UNKNOWN

• Hospital Universitario de Burgos

  collaborator OTHER

• Hospital Universitario de Cáceres

  collaborator UNKNOWN

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario Rio Hortega

  collaborator UNKNOWN

• Hospital Mutua de Terrassa

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-19

Primary Completion

2023-09-15

Completion

2023-12-31

Countries

• Spain

Study Locations