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Open Access 01-12-2023 | Crohn's Disease | Study protocol

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

Authors: Carme Loras, Pablo Ruiz-Ramirez, Juan Romero, Xavier Andújar, Josep Bargallo, Esther Bernardos, Marta Maia Boscá-Watts, Carlo Brugiotti, Eduard Brunet, David Busquets, Elena Cerrillo, Francisco Javier Cortina, Juan Antonio Díaz-Milanés, Carmen Dueñas, Ramón Farrés, Thomas Golda, Ferran González-Huix, Joan B. Gornals, Jordi Guardiola, David Julià, Alba Lira, Jordina Llaó, Miriam Mañosa, Ingrid Marin, Mónica Millán, David Monfort, David Moro, Josep Mullerat, Mercè Navarro, Francisco Pérez Roldán, Eva Pijoan, Vicente Pons, José Reyes, María Rufas, Empar Sainz, Vicente Sanchiz, Anna Serracant, Eva Sese, Cristina Soto, Jose Troya, Natividad Zaragoza, Cristian Tebé, Marta Paraira, Emma Sudrià-Lopez, Vicenç Mayor, Fernando Fernández-Bañares, Maria Esteve, on behalf of the Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU

Published in: Trials | Issue 1/2023

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.

Trial registration

ClinicalTrials.gov NCT 04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home

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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
Authors: Carme Loras
Pablo Ruiz-Ramirez
Juan Romero
Xavier Andújar
Josep Bargallo
Esther Bernardos
Marta Maia Boscá-Watts
Carlo Brugiotti
Eduard Brunet
David Busquets
Elena Cerrillo
Francisco Javier Cortina
Juan Antonio Díaz-Milanés
Carmen Dueñas
Ramón Farrés
Thomas Golda
Ferran González-Huix
Joan B. Gornals
Jordi Guardiola
David Julià
Alba Lira
Jordina Llaó
Miriam Mañosa
Ingrid Marin
Mónica Millán
David Monfort
David Moro
Josep Mullerat
Mercè Navarro
Francisco Pérez Roldán
Eva Pijoan
Vicente Pons
José Reyes
María Rufas
Empar Sainz
Vicente Sanchiz
Anna Serracant
Eva Sese
Cristina Soto
Jose Troya
Natividad Zaragoza
Cristian Tebé
Marta Paraira
Emma Sudrià-Lopez
Vicenç Mayor
Fernando Fernández-Bañares
Maria Esteve
on behalf of the Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU
Publication date: 01-12-2023
Publisher: BioMed Central
Keyword: Crohn's Disease
Published in: Trials / Issue 1/2023
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-023-07447-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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