Status:
RECRUITING
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Lead Sponsor:
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Conditions:
Crohn Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 (1-3). E...
Detailed Description
In many cases, a surgical approach allows for the removal of the entire inflamed intestine. However, the percentage of post-surgical recurrence per year after surgery is 80-85% (7), decreasing to 40% ...
Eligibility Criteria
Inclusion
- 18-80 years of age.
- Crohn's disease with predominantly de novo fibrotic stenosis\* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
- Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion.
- Symptomatology of intestinal occlusion-subocclusion.
- Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).
- Stenosis length \< 10 cm.
- Maximum of 2 stenoses.
- Informed consent from patient.
Exclusion
- No informed consent from the patient.
- Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
- Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion.
- Pregnancy or lactation.
- Any clinical situation that prevents the performance of endoscopy or surgery.
- Stenosis not accessible by endoscopy.
- Asymptomatic patient.
- Stenosis length ≥ 10 cm.
- Presents with \> 2 stenoses.
- Severe coagulation disorders (platelets \< 70000; INR \> 1.8).
Key Trial Info
Start Date :
November 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04330846
Start Date
November 29 2022
End Date
April 1 2027
Last Update
August 19 2025
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
3
Althaia, xarxa assistencial universitaria de Manresa
Manresa, Barcelona, Spain, 08243
4
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208