NCT04330846Recruiting
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Crohn's Disease. Endoscopic Treatment (Self-expanding Metal Prosthesis/Ballon Dilation) vc Surgical Resection (ENDOCIR STUDY)
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Mar 2020
- Start date
- 29 Nov 2022
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Diseases
- Crohn's disease
- NCT number
- NCT04330846
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 29 Nov 2022 to the primary completion date, 1 Apr 2026
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion.
- Any clinical situation that prevents the performance of endoscopy or surgery.
Other illness
- Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
Lab values
- Severe coagulation disorders (platelets \< 70000; INR \> 1.8).
Other
- No informed consent from the patient.
- Pregnancy or lactation.
- Stenosis not accessible by endoscopy.
- Asymptomatic patient.
- Stenosis length ≥ 10 cm.
- Presents with \> 2 stenoses.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Hospital Universitario De Caceres Coordinator of this site? Confirm its status | Caceres | Spain | Recruiting |
| Clínica Girona Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital Josep Trueta Coordinator of this site? Confirm its status | Girona | Spain | Not yet recruiting |
| Hospital de Inca Coordinator of this site? Confirm its status | Inca | Spain | Not yet recruiting |
| Hospital Universitario de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitari Arnau de Vilanova Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| ALTHAIA, Xarxa Assistencial Universitaria de Manresa. Coordinator of this site? Confirm its status | Manresa | Spain | Not yet recruiting |
| Consorci Corporació Sanitària Parc Taulí Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Moisès Broggi Coordinator of this site? Confirm its status | Sant Joan Despí | Spain | Not yet recruiting |
| Hospital de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Not yet recruiting |
| Hospital Mutua de Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Recruiting |
| Hospital Clínico de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Universitari La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.