Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Recruiting · NCT04330846 · Interventional (participants receive a specific treatment) · Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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).
Where it is running
16 locations listed.
- Hospital Universitario de Cáceres - Cáceres, Spain
- Clínica Girona - Girona, Spain
- Hospital Josep Trueta - Girona, Spain
- Hospital de Inca - Inca, Spain
- Hospital Universitari Arnau de Vilanova - Lleida, Spain
- Hospital Universitario La Paz - Madrid, Spain
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital de Terrassa - Terrassa, Spain
- Hospital Clínico de Valencia - Valencia, Spain
- Hospital Universitari La Fe - Valencia, Spain
- Hospital Germans Trias i Pujol - Badalona, Barcelona, Spain
- Hospital Universitario de Bellvitge - L'Hospitalet de Llobregat, Barcelona, Spain
- Althaia, xarxa assistencial universitaria de Manresa - Manresa, Barcelona, Spain
- Consorci Corporació Sanitària Parc Taulí - Sabadell, Barcelona, Spain
- Hospital Moisès Broggi - Sant Joan Despí, Barcelona, Spain
- Hospital Mutua de Terrassa - Terrassa, Barcelona, Spain