Compares treatments for narrowing of the bowel in Crohn disease
Compares endoscopic treatment with surgery for new bowel narrowing in adults with Crohn disease.
Plain-language title generated from the registry record
Registry title: Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Key facts
- Where
- Badalona, Caceres, Girona, Inca, L'Hospitalet de Llobregat, Lleida, Madrid, Manresa, Sabadell, Sant Joan Despí, Terrassa, and Valencia, SpainSee the 16 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04330846, who can take part
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainNot yet recruiting
- Hospital Universitario De CaceresCaceres, SpainTaking people
- Clínica GironaGirona, SpainNot yet recruiting
- Hospital Josep TruetaGirona, SpainNot yet recruiting
- Hospital de IncaInca, SpainNot yet recruiting
- Hospital Universitario de BellvitgeL'Hospitalet de Llobregat, SpainNot yet recruiting
- Hospital Universitari Arnau de VilanovaLleida, SpainTaking people
- Hospital Universitario La PazMadrid, SpainNot yet recruiting
- Hospital Universitario Ramón y CajalMadrid, SpainNot yet recruiting
- ALTHAIA, Xarxa Assistencial Universitaria de Manresa.Manresa, SpainNot yet recruiting
- Consorci Corporació Sanitària Parc TaulíSabadell, SpainTaking people
- Hospital Moisès BroggiSant Joan Despí, SpainNot yet recruiting
- Hospital de TerrassaTerrassa, SpainNot yet recruiting
- Hospital Mutua de TerrassaTerrassa, SpainTaking people
- Hospital Clínico de ValenciaValencia, SpainNot yet recruiting
- Hospital Universitari La FeValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
- Trial code
- NCT04330846
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis; Severe coagulation disorders (platelets < 70000; INR > 1.8); No informed consent from the patient; Pregnancy or lactation; Stenosis not accessible by endoscopy; Asymptomatic patient; Stenosis length ≥ 10 cm; Presents with > 2 stenoses.