Status:
UNKNOWN
Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
Lead Sponsor:
Hospital Mutua de Terrassa
Collaborating Sponsors:
Clínica Girona
Complejo Hospitalario Universitario de Vigo
Conditions:
Crohn Disease
Stenosis
Eligibility:
All Genders
18-75 years
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. Several...
Eligibility Criteria
Inclusion
- Age18-75.
- CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy).
- Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic.
- Intestinal occlusion or sub-occlusion symptomatology.
- Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale).
- Stenosis length \< 10 cm.
- Maximum 2 stenoses.
- Informed consent of patient.
Exclusion
- No informed consent of patient.
- Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area.
- Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic.
- Pregnancy or lactation.
- Any clinical condition that prevents the performance of endoscopy.
- Stenosis inaccessible by colonoscopy.
- No obstructive symptoms.
- Stenosis length ≥ 10 cm.
- Presenting more than 2 stenoses.
- Serious coagulation disorder (platelets \< 70000; INR \> 1.5)
Key Trial Info
Start Date :
December 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06036680
Start Date
December 19 2022
End Date
December 31 2023
Last Update
September 14 2023
Active Locations (1)
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1
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221