Comparing surgical and endoscopic treatments for new stenosis in Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Consorci Corporació Sanitària Parc Taulí
  Sabadell, Barcelona, Spain Recruiting
• Hospital Mutua de Terrassa
  Terrassa, Barcelona, Spain Recruiting
• Hospital Universitario de Cáceres
  Cáceres, Spain Recruiting
• Hospital Universitari Arnau de Vilanova
  Lleida, Spain Recruiting
• Hospital Universitari La Fe
  Valencia, Spain Recruiting
• Hospital Germans Trias i Pujol
  Badalona, Barcelona, Spain Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.