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RECRUITING
NCT04330846
NA

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

View on ClinicalTrials.gov

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

PROCEDURE

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