Crohn'sRecruiting
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Not applicable · Testing Surgical resection · 16 sites · Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Surgical resection (a procedure) as a way to diagnose or measure disease. Condition(s) listed: Crohn Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 80
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 5 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2022-11-29.
- Main results expected around 2026-04-01 (estimate from the record).
- 16 study sites listed (5 marked recruiting) in Spain.
Main thing being measured
- Quality of life of patients (One year of follow-up)
In the researchers’ words
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).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| Enrollment | 40 (estimated) |
| Start date | 2022-11-29 |
| Primary completion (est.) | 2026-04-01 |
| First posted | 2020-04-02 |
| Last updated | 2025-08-19 |
| Official title | 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) |
| ClinicalTrials.gov ID | NCT04330846 |
Interventions
- Surgical resection (Procedure)
The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
Full eligibility criteria (from the record)
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).
Locations (16)
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Cáceres | Cáceres | Spain | Recruiting |
| Clínica Girona | Girona | Spain | Not yet recruiting |
| Hospital Josep Trueta | Girona | Spain | Not yet recruiting |
| Hospital de Inca | Inca | Spain | Not yet recruiting |
| Hospital Universitari Arnau de Vilanova | Lleida | Spain | Recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Ramon y Cajal | Madrid | Spain | Not yet recruiting |
| Hospital de Terrassa | Terrassa | Spain | Not yet recruiting |
| Hospital Clínico de Valencia | Valencia | Spain | Not yet recruiting |
| Hospital Universitari La Fe | Valencia | Spain | Recruiting |
| Hospital Germans Trias i Pujol | Badalona, Barcelona | Spain | Not yet recruiting |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat, Barcelona | Spain | Not yet recruiting |
| Althaia, xarxa assistencial universitaria de Manresa | Manresa, Barcelona | Spain | Not yet recruiting |
| Consorci Corporació Sanitària Parc Taulí | Sabadell, Barcelona | Spain | Recruiting |
| Hospital Moisès Broggi | Sant Joan Despí, Barcelona | Spain | Not yet recruiting |
| Hospital Mutua de Terrassa | Terrassa, Barcelona | Spain | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.