Actively Recruiting
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2025-08-19
40
Participants Needed
16
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.
CONDITIONS
Official Title
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 to 80 years of age
- Crohn's disease with mainly new fibrotic stenosis confirmed by endoscopic and radiological tests accessible by colonoscopy
- Patients with stenosis treated by stenting and/or dilation more than one year before enrollment
- Symptoms of intestinal blockage or partial blockage
- No response to conventional medical treatment
- Stenosis length less than 10 cm
- Maximum of two stenoses
- Patient provides informed consent
You will not qualify if you...
- No informed consent given
- Complicated stenosis with abscess, fistula, or significant Crohn's activity beyond stenosis area
- Stenosis treated by stenting and/or dilation less than one year before enrollment
- Pregnancy or breastfeeding
- Any condition preventing endoscopy or surgery
- Stenosis not accessible by endoscopy
- No symptoms present
- Stenosis length 10 cm or more
- More than two stenoses
- Severe blood clotting disorders (platelets below 70000 or INR above 1.8)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Not Yet Recruiting
2
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Not Yet Recruiting
3
Althaia, xarxa assistencial universitaria de Manresa
Manresa, Barcelona, Spain, 08243
Not Yet Recruiting
4
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
5
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain, 08970
Not Yet Recruiting
6
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Actively Recruiting
7
Hospital Universitario de Cáceres
Cáceres, Spain
Actively Recruiting
8
Clínica Girona
Girona, Spain
Not Yet Recruiting
9
Hospital Josep Trueta
Girona, Spain
Not Yet Recruiting
10
Hospital de Inca
Inca, Spain
Not Yet Recruiting
11
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Actively Recruiting
12
Hospital Universitario La Paz
Madrid, Spain, 28046
Not Yet Recruiting
13
Hospital Universitario Ramon y Cajal
Madrid, Spain
Not Yet Recruiting
14
Hospital de Terrassa
Terrassa, Spain
Not Yet Recruiting
15
Hospital Clínico de Valencia
Valencia, Spain, 46010
Not Yet Recruiting
16
Hospital Universitari La Fe
Valencia, Spain
Actively Recruiting
Research Team
A
Anna Casas
CONTACT
E
Eugeni Domènech
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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