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.

Data de publicació: 27/06/2023 Data Ahead of Print: 27/06/2023

Autors de IIS La Fe

Autors aliens a IIS La Fe

Loras C
Ruiz-Ramirez P
Romero J
Andújar X
Bargallo J
Bernardos E
Boscá-Watts MM
Brugiotti C
Brunet E
Busquets D
Cortina FJ
Díaz-Milanés JA
Dueñas C
Farrés R
Golda T
González-Huix F
Gornals JB
Guardiola J
Julià D
Lira A
Llaó J
Mañosa M
Marin I
Monfort D
Moro D
Mullerat J
Navarro M
Pérez Roldán F
Pijoan E
Reyes J
Rufas M
Sainz E
Sanchiz V
Serracant A
Sese E
Soto C
Troya J
Zaragoza N
Tebé C
Paraira M
Sudrià-Lopez E
Mayor V
Fernández-Bañares F
Esteve M
Grupo Español de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU

Grups d'Investigació

Cirugía digestiva y Cuidados perioperatorios

Leader

Matteo Frasson
Endoscopia Digestiva y Hepática

Leader

Vicente Pons Beltrán
Enfermedad Inflamatoria Intestinal

Leader

Pilar Nos Mateu

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 NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.

Dades de la publicació

ISSN/ISSNe:: 1745-6215, 1745-6215
Tipus:: Article
Pàgines:: 432-432
DOI:: 10.1186/s13063-023-07447-1
PubMed:: 37365665
Factor d'Impacte:: 0,865 SCImago ℠
Quartil:: Q1 SCImago ℠

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Keywords

Balloon dilation; Crohn’s disease; De novo or primary stenosis; Endoscopic treatment; Proof-of-concept study; Randomized clinical trial; Self-expandable metal stent; Surgical resection