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Title: | 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. |
Author: | Brunet, Eduard Sainz, Empar Loras, Carme Ruiz‑Ramirez, Pablo Romero, Juan Andújar, Xavier Bargallo, Josep Bernardos, Esther Boscá‑Watts, Marta Maia Brugiotti, Carlo Busquets, David Cerrillo, Elena Cortina, Francisco Javier Díaz‑Milanés, Juan Antonio Dueñas, Carmen Farrés, Ramón Golda, Thomas González-Huix Lladó, Ferran Gornals Soler, 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 Sanchiz, Vicente Serracant, Anna Sesé, Eva Soto, Cristina Troya, José Zaragoza, Natividad Tebé, Cristian Paraira Beser, Marta Sudrià‑Lopez, Emma Mayor, Vicenç Fernández Bañares, Fernando Esteve, Maria Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU. |
Keywords: | Malaltia de Crohn Qualitat de vida Pròtesis de Stent Crohn's disease Quality of life Stents (Surgery) |
Issue Date: | 27-Jun-2023 |
Publisher: | BioMed Central |
Abstract: | Background: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. 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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/s13063-023-07447-1 |
It is part of: | Trials, 2023, vol. 24, num.1 |
URI: | http://hdl.handle.net/2445/208692 |
Related resource: | https://doi.org/10.1186/s13063-023-07447-1 |
ISSN: | 1745-6215 |
Appears in Collections: | Articles publicats en revistes (Medicina) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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