Comparing surgical and endoscopic treatments for new stenosis in Crohn'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)
This study is testing whether surgery or a less invasive balloon treatment works better for people with new blockages in their intestines caused by Crohn's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa Academic / other |
| Locations | 16 sites (Badalona, Barcelona and 15 other locations) |
| Trial ID | NCT04330846 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and complications of surgical resection versus endoscopic balloon dilation (EBD) for treating de novo stenosis in patients with Crohn's disease. It will involve patients aged 18-80 with confirmed fibrotic stenosis less than 10 cm in length, who have not responded to conventional medical treatments. The study will evaluate not only the clinical outcomes but also the impact on patients' quality of life and the associated costs of each treatment approach. By gathering data from multiple centers, the study seeks to provide evidence-based recommendations for managing this common complication of Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with Crohn's disease and de novo fibrotic stenosis less than 10 cm, who have not responded to standard medical treatments.
Not a fit: Patients with complicated stenosis involving abscesses or fistulas, or those who have had recent treatment for stenosis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for treating de novo stenosis in Crohn's disease, potentially improving patient outcomes and quality of life.
How similar studies have performed: While there is limited comparative research on these treatment modalities, previous studies have shown promising results for endoscopic treatments in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Badalona, Barcelona and 15 other locations
- 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)
- 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)
Study contacts
- Principal investigator: Carme Loras — Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Study coordinator: Anna Casas
- Email: secretariacientifica2@geteccu.org
- Phone: 635 899 553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.