Clinical Research Directory
Browse clinical research sites, groups, and studies.
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2022-11-29
Completion Date
2027-04-01
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
Surgical resection
The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
Locations (16)
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Althaia, xarxa assistencial universitaria de Manresa
Manresa, Barcelona, Spain
Consorci Corporació Sanitària Parc Taulí
Sabadell, Barcelona, Spain
Hospital Moisès Broggi
Sant Joan Despí, Barcelona, Spain
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario de Cáceres
Cáceres, Spain
Clínica Girona
Girona, Spain
Hospital Josep Trueta
Girona, Spain
Hospital de Inca
Inca, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital de Terrassa
Terrassa, Spain
Hospital Clínico de Valencia
Valencia, Spain
Hospital Universitari La Fe
Valencia, Spain