Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.

NCT04330846 | Recruiting DMC

• 1 other identifier: ENDOCIR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Crohn Disease

Keywords

crohn

Outcome Measures

Primary Outcomes (1)

• Quality of life of patients

  Percentage of patients with an increase of more than 30 points in the Inflammatory Bowel Disease Questionnaire (IBDQ-32) quality of life index. The higher the better.

  One year of follow-up

Secondary Outcomes (2)

• Percentage of patients with clinical recurrence

  One year of follow-up

• Percentage of complications

  One year of follow-up

Study Arms (2)

EBD group

EXPERIMENTAL

* Post-procedural admission in the Short Stay Unit (SSU). * Superficial sedation by endoscopist or anesthesiologist depending on the center. * Pneumatic balloon type CRE Boston scientific®; diameter of the balloon at the endoscopist's discretion. * A maximum of 2 dilations will be performed with a minimum interval of 15-30 days between each dilation. * Dilation failure will be considered if \> 2 dilations are required.

Procedure: Surgical resection

SEMS group

EXPERIMENTAL

* Post-procedural admission in the Short Stay Unit (SSU). * Superficial sedation by endoscopist or anesthesiologist depending on the center. * Fully coated, self-expanding Tae Woong medical®-type metal prostheses; size of the prostheses at the discretion of the endoscopist * Clips can be placed at the distal end of the prosthesis at the endoscopist's discretion. * Removal time of the prosthesis 4 weeks.

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.

EBD group; SEMS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Crohn's disease with predominantly de novo fibrotic stenosis\* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
• Symptomatology of intestinal occlusion-subocclusion.
• Refractoriness to conventional medical treatment (non-response to the usual accelerated step-up therapeutic approach).
• Stenosis length \< 10 cm.
• Maximum of 2 stenoses.
• Informed consent from patient.

You may not qualify if:

• No informed consent from the patient.
• Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.
• Pregnancy or lactation.
• Any clinical situation that prevents the performance of endoscopy or surgery.
• Stenosis not accessible by endoscopy.
• Asymptomatic patient.
• Stenosis length ≥ 10 cm.
• Presents with \> 2 stenoses.
• Severe coagulation disorders (platelets \< 70000; INR \> 1.8).

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (16)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

NOT YET RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

NOT YET RECRUITING

Althaia, xarxa assistencial universitaria de Manresa

Manresa, Barcelona, 08243, Spain

NOT YET RECRUITING

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

NOT YET RECRUITING

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Hospital Universitario de Cáceres

Cáceres, Spain

RECRUITING

Clínica Girona

Girona, Spain

NOT YET RECRUITING

Hospital Josep Trueta

Girona, Spain

NOT YET RECRUITING

Hospital de Inca

Inca, Spain

NOT YET RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

NOT YET RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, Spain

NOT YET RECRUITING

Hospital de Terrassa

Terrassa, Spain

NOT YET RECRUITING

Hospital Clínico de Valencia

Valencia, 46010, Spain

NOT YET RECRUITING

Hospital Universitari La Fe

Valencia, Spain

RECRUITING

Related Publications (19)

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• Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn's disease. Gastroenterology. 1990 Oct;99(4):956-63. doi: 10.1016/0016-5085(90)90613-6.

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• Peyrin-Biroulet L, Deltenre P, Ardizzone S, D'Haens G, Hanauer SB, Herfarth H, Lemann M, Colombel JF. Azathioprine and 6-mercaptopurine for the prevention of postoperative recurrence in Crohn's disease: a meta-analysis. Am J Gastroenterol. 2009 Aug;104(8):2089-96. doi: 10.1038/ajg.2009.301. Epub 2009 Jun 30.

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• Loras C, Mayor V, Fernandez-Banares F, Esteve M. Study of the standard direct costs of various techniques of advanced endoscopy. Comparison with surgical alternatives. Dig Liver Dis. 2018 Jul;50(7):689-697. doi: 10.1016/j.dld.2018.03.002. Epub 2018 Mar 12.

  PMID: 29610018 BACKGROUND

• Wright EK, Kamm MA. Impact of drug therapy and surgery on quality of life in Crohn's disease: a systematic review. Inflamm Bowel Dis. 2015 May;21(5):1187-94. doi: 10.1097/MIB.0000000000000271.

  PMID: 25895008 BACKGROUND

• Gionchetti P, Dignass A, Danese S, Magro Dias FJ, Rogler G, Lakatos PL, Adamina M, Ardizzone S, Buskens CJ, Sebastian S, Laureti S, Sampietro GM, Vucelic B, van der Woude CJ, Barreiro-de Acosta M, Maaser C, Portela F, Vavricka SR, Gomollon F; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 2: Surgical Management and Special Situations. J Crohns Colitis. 2017 Feb;11(2):135-149. doi: 10.1093/ecco-jcc/jjw169. Epub 2016 Sep 22.

  PMID: 27660342 BACKGROUND

• Bemelman WA, Warusavitarne J, Sampietro GM, Serclova Z, Zmora O, Luglio G, de Buck van Overstraeten A, Burke JP, Buskens CJ, Colombo F, Dias JA, Eliakim R, Elosua T, Gecim IE, Kolacek S, Kierkus J, Kolho KL, Lefevre JH, Millan M, Panis Y, Pinkney T, Russell RK, Shwaartz C, Vaizey C, Yassin N, D'Hoore A. ECCO-ESCP Consensus on Surgery for Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):1-16. doi: 10.1093/ecco-jcc/jjx061. No abstract available.

  PMID: 28498901 BACKGROUND

• Andujar X, Loras C, Gonzalez B, Socarras M, Sanchiz V, Bosca M, Domenech E, Calafat M, Rodriguez E, Sicilia B, Calvet X, Barrio J, Guardiola J, Iglesias E, Casanova MJ, Ber Y, Monfort D, Lopez-Sanroman A, Rodriguez-Lago I, Bujanda L, Marquez L, Martin-Arranz MD, Zabana Y, Fernandez-Banares F, Esteve M; ENEIDA registry of GETECCU. Efficacy and safety of endoscopic balloon dilation in inflammatory bowel disease: results of the large multicenter study of the ENEIDA registry. Surg Endosc. 2020 Mar;34(3):1112-1122. doi: 10.1007/s00464-019-06858-z. Epub 2019 May 29.

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• Attar A, Maunoury V, Vahedi K, Vernier-Massouille G, Vida S, Bulois P, Colombel JF, Bouhnik Y; GETAID. Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: a prospective pilot study. Inflamm Bowel Dis. 2012 Oct;18(10):1849-54. doi: 10.1002/ibd.22844. Epub 2011 Dec 11.

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  PMID: 21542067 BACKGROUND

• Loras C, Perez-Roldan F, Gornals JB, Barrio J, Igea F, Gonzalez-Huix F, Gonzalez-Carro P, Perez-Miranda M, Espinos JC, Fernandez-Banares F, Esteve M. Endoscopic treatment with self-expanding metal stents for Crohn's disease strictures. Aliment Pharmacol Ther. 2012 Nov;36(9):833-9. doi: 10.1111/apt.12039.

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• Loras Alastruey C, Andujar Murcia X, Esteve Comas M. The role of stents in the treatment of Crohn's disease strictures. Endosc Int Open. 2016 Mar;4(3):E301-8. doi: 10.1055/s-0042-101786.

  PMID: 27014743 BACKGROUND

• Multicenter prospective randomized study to compare endoscopic treatment of strictures in crohn´s disease: self-expanding metal stents vs endoscopic balloon dilation. Protdilat study. Andujar X, Loras Alastruey C, Gornals J.B, Guardiola J., Sanchiz V., Bosca M., Brullet E., Sicília Aladrén B., Naranjo Rodríguez A., Martín-Arranz M.D., Dueñas-Sadornil C., Foruny J.R., Barrio Andrés J., Monfort Miquel D., Busquets Casals D., Pineda J.R., Pérez-Roldán F., Pons Beltrán V., González-Huix Lladó F., Sainz E., Gonzalez B.9,, Reyes Moreno J., Fernández-Bañares F.9,, Esteve M. 27rd United European Gastroenterology Week (UEGW). Barcelona 2019. UNITED EUROPEAN GASTROENTEROLOGY Barcelona 22- 24 October 2019.

  BACKGROUND

• Loras C, Ruiz-Ramirez P, Romero J, Andujar X, Bargallo J, Bernardos E, Bosca-Watts MM, Brugiotti C, Brunet E, Busquets D, Cerrillo E, Cortina FJ, Diaz-Milanes JA, Duenas C, Farres R, Golda T, Gonzalez-Huix F, Gornals JB, Guardiola J, Julia D, Lira A, Llao J, Manosa M, Marin I, Millan M, Monfort D, Moro D, Mullerat J, Navarro M, Perez Roldan F, Pijoan E, Pons V, Reyes J, Rufas M, Sainz E, Sanchiz V, Serracant A, Sese E, Soto C, Troya J, Zaragoza N, Tebe C, Paraira M, Sudria-Lopez E, Mayor V, Fernandez-Banares F, Esteve M; Grupo Espanol de Trabajo de la Enfermedad de Crohn y Colitis Ulcerosa GETECCU. 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. Trials. 2023 Jun 27;24(1):432. doi: 10.1186/s13063-023-07447-1.

  PMID: 37365665 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Carme Loras

  Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Casas

CONTACT

635 899 553; secretariacientifica2@geteccu.org

Eugeni Domènech

CONTACT

eugenidomenech@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective multicenter randomized comparative study of the treatment of de novo stenosis due to CD, comparing endoscopic treatment (stent or EBD) vs. surgical resection (SR). The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 2, 2020
• Study Start: November 29, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (16)