Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.
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Loras Carme, Ruiz-Ramirez Pablo, Romero Juan, Andújar Xavier, Bargallo Josep, Bernardos Esther, Boscá-Watts Marta Maia, Brugiotti Carlo, Brunet Eduard, Busquets David, Cerrillo Elena, Cortina Francisco Javier, Díaz-Milanés Juan Antonio, Dueñas Carmen, Farrés Ramón, Golda Thomas, González-Huix Ferran, Gornals Joan B, Guardiola Jordi, Julià David, Lira Alba, Llaó Jordina, Mañosa Miriam, Marin Ingrid, Millán Mónica, Monfort David, Moro David, Mullerat Josep, Navarro Mercè, Pérez Roldán Francisco, Pijoan Eva, Pons Vicente, Reyes José, Rufas María, Sainz Empar, Sanchiz Vicente, Serracant Anna, Sese Eva, Soto Cristina, Troya Jose, Zaragoza Natividad, Tebé Cristian, Paraira Marta, Sudrià-Lopez Emma, Mayor Vicenç, Fernández-Bañares Fernando, Esteve Maria, Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU
Аннотация
METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up.
DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.