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Crohn DiseaseENDOCIRNCT04330846

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

A study testing Surgical resection in people with Crohn Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 16 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Crohn Disease
What is being tested?
Surgical resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
16 sitesSpain
Study dates
29 Nov 2022to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years of age.
  • Crohn's disease with predominantly de novo fibrotic stenosis* confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
  • Patients with known stenosis previously treated with stenting and/or dilation performed over one year before the date of inclusion.
  • 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.

Who cannot join

  • 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.
  • Patients with known stenosis previously treated with stenting and/or dilation performed < 1 year before the date of inclusion.
  • Pregnancy or lactation.
  • Any clinical situation that prevents the performance of endoscopy or surgery.
  • Stenosis not accessible by endoscopy.
Show all 10Show fewer
  • Asymptomatic patient.
  • Stenosis length ≥ 10 cm.
  • Presents with > 2 stenoses.
  • Severe coagulation disorders (platelets < 70000; INR > 1.8).

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Casas contact

635 899 553

secretariacientifica2@geteccu.org

Eugeni Domènech contact

eugenidomenech@gmail.com

16 sites in 1 country

Spain16 sites, 16 recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Ingrid Marin, MD

    Not yet recruiting

  • Hospital Universitario de Cáceres

    Cáceres

    Carmen Dueñas, MD

    Recruiting

  • Clínica Girona

    Girona

    Not yet recruiting

  • Hospital Josep Trueta

    Girona

    Xavier Aldeguer, Dr

    David Busquets, MD

    Not yet recruiting

  • Hospital de Inca

    Inca

    José Reyes, MD

    Not yet recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

    Joan Gonals, MD

    Not yet recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

    Ferran Gonzalez-Huix, MD

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Mariló Martín, MD

    Not yet recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid

    Paco Mesonero, MD

    Not yet recruiting

  • Althaia, xarxa assistencial universitaria de Manresa

    Manresa, Barcelona, 08243

    Empar Sainz, MD

    Not yet recruiting

  • Consorci Corporació Sanitària Parc Taulí

    Sabadell, Barcelona, 08208

    Albert Villoria, MD

    Recruiting

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08970

    Mercè Navarro, MD

    Not yet recruiting

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

    Carme Loras, MD

    Recruiting

  • Hospital de Terrassa

    Terrassa

    David Monfort, MD

    Not yet recruiting

  • Hospital Clínico de Valencia

    Valencia, 46010

    MÍGUEL MÍNGUEZ PÉREZ, MD

    Maia Boscó, MD

    Not yet recruiting

  • Hospital Universitari La Fe

    Valencia

    Elena Cerrillo, MD

    Recruiting

Other trials in Spain

About this study

Official title: Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Crohn's Disease. Endoscopic Treatment (Self-expanding Metal Prosthesis/Ballon Dilation) vc Surgical Resection (ENDOCIR STUDY)

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.

Read the detailed description

In many cases, a surgical approach allows for the removal of the entire inflamed intestine. However, the percentage of post-surgical recurrence per year after surgery is 80-85% (7), decreasing to 40% in patients who begin preventive immunosuppressive treatment in the immediate post-surgery period (8). This means that more than 40% of patients will require combined immunosuppression to keep CD under control one year after surgery. Endoscopic treatment does not remove the affected intestine. However, it has a long-term therapeutic efficacy of 50-60% with a very low percentage of complications (4-6%).

A large number of studies have shown that patients' quality of life improves when CD is properly controlled, either through medical or surgical treatment (9). However, there are no studies evaluating the quality of life of patients after endoscopic treatment.

Neither are there comparative studies of the costs of the two procedures. However, a recent study comparing the cost of 38 endoscopic procedures with their surgical equivalent suggested that, in most cases, the cost of endoscopic treatment is four times lower (10).

The European Crohn's and Colitis Organization (ECCO) guidelines on the management of de novo stenosis in patients with CD recommend surgery as the first option, based on expert opinion (Level of Evidence 4), although there are no studies comparing the two treatment modalities (11,12).

A Spanish multicenter study coordinated by researchers involved in the present project (Andujar X, et al)(13), which included the largest published series of endoscopic treatment with dilation in patients with CD to date, shows that therapeutic success with EBD in de novo stenoses is achieved in a large percentage of cases, with results similar to those obtained in post-surgical stenoses (73% vs 84%).

In addition, CD stenoses can be treated effectively with self-expanding metal stents (SEMS), and it has been suggested that these may be particularly indicated in patients who are refractory to balloon dilation, including both de novo and anastomotic stenosis patients (14-17). Therefore, in order to compare the efficacy of these two endoscopic treatments, the PROTDILAT study (IP: C Loras. Project FIS nº Pl13/01226 and Clinical Trials. Gov nº NCT02395354) was designed, and is currently in the final manuscript writing phase (100 patients included). The final results (Andújar X, UEGW 2019)(18) confirm that both procedures are effective and safe in the treatment of both post-surgical and de novo stenosis, while showing the therapeutic superiority of EBD over SEMS when the results are evaluated globally (80.5 vs 51.3 %; primary end point). However, this difference is not observed in the subanalysis of patients with stenosis ≥4 cm (LBD: 66.7% vs PMA: 63.6%) but with a significantly lower cost in EDB treatment (EDB 1,212.41 euros vs PMA 3,615.07 euros). Therefore, SEMS may have a role to play in longer stenosis in which EBD has proven to be less efficacious.

This work has been conceived as an exploratory proof of concept study, given that there are currently no studies comparing surgical and endoscopic approaches and it is therefore difficult to calculate the adequate sample size.

Conditions
Crohn Disease
Being tested
Surgical resection
Keywords
crohn
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical resectionProcedure or surgery

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

Study groups in NCT04330846
Study groupRoleWhat they receive
EBD groupExperimental* 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.
Receives: Procedure: Surgical resection
SEMS groupExperimental* 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.
Receives: Procedure: Surgical resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: One year of follow-up

Secondary outcomes (2)

  1. Percentage of patients with clinical recurrence

    Percentage of patients with clinical recurrence (scale of obstructive symptoms 0-6) and costs. The lower the better.

    Measured: One year of follow-up

  2. Percentage of complications

    Percentage of complications and costs.

    Measured: One year of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start29 Nov 2022
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04330846
Sponsor's protocol ID
ENDOCIR
Acronym
ENDOCIR
Status last verified
Aug 2025
First submitted
25 Mar 2020
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cosnes J, Gower-Rousseau C, Seksik P, Cortot A. Epidemiology and natural history of inflammatory bowel diseases. Gastroenterology. 2011 May;140(6):1785-94. doi: 10.1053/j.gastro.2011.01.055.

    PubMed 21530745

  • Solberg IC, Vatn MH, Hoie O, Stray N, Sauar J, Jahnsen J, Moum B, Lygren I; IBSEN Study Group. Clinical course in Crohn's disease: results of a Norwegian population-based ten-year follow-up study. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1430-8. doi: 10.1016/j.cgh.2007.09.002.

    PubMed 18054751

  • Peyrin-Biroulet L, Loftus EV Jr, Colombel JF, Sandborn WJ. The natural history of adult Crohn's disease in population-based cohorts. Am J Gastroenterol. 2010 Feb;105(2):289-97. doi: 10.1038/ajg.2009.579. Epub 2009 Oct 27.

    PubMed 19861953

  • Hassan C, Zullo A, De Francesco V, Ierardi E, Giustini M, Pitidis A, Taggi F, Winn S, Morini S. Systematic review: Endoscopic dilatation in Crohn's disease. Aliment Pharmacol Ther. 2007 Dec;26(11-12):1457-64. doi: 10.1111/j.1365-2036.2007.03532.x. Epub 2007 Sep 28.

    PubMed 17903236

  • Morar PS, Faiz O, Warusavitarne J, Brown S, Cohen R, Hind D, Abercrombie J, Ragunath K, Sanders DS, Arnott I, Wilson G, Bloom S, Arebi N; Crohn's Stricture Study (CroSS) Group. Systematic review with meta-analysis: endoscopic balloon dilatation for Crohn's disease strictures. Aliment Pharmacol Ther. 2015 Nov;42(10):1137-48. doi: 10.1111/apt.13388. Epub 2015 Sep 11.

    PubMed 26358739

  • Navaneethan U, Lourdusamy V, Njei B, Shen B. Endoscopic balloon dilation in the management of strictures in Crohn's disease: a systematic review and meta-analysis of non-randomized trials. Surg Endosc. 2016 Dec;30(12):5434-5443. doi: 10.1007/s00464-016-4902-1. Epub 2016 Apr 28.

    PubMed 27126619

  • 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.

    PubMed 2394349

  • 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.

    PubMed 19568226

  • 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.

    PubMed 29610018

  • 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.

    PubMed 25895008

  • 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.

    PubMed 27660342

  • 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.

    PubMed 28498901

  • 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.

    PubMed 31144122

  • 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.

    PubMed 22161935

  • Levine RA, Wasvary H, Kadro O. Endoprosthetic management of refractory ileocolonic anastomotic strictures after resection for Crohn's disease: report of nine-year follow-up and review of the literature. Inflamm Bowel Dis. 2012 Mar;18(3):506-12. doi: 10.1002/ibd.21739. Epub 2011 May 3.

    PubMed 21542067

Questions about this trial

What is this clinical trial studying?

A study testing Surgical resection in people with Crohn Disease, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 16 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Casas (635 899 553, secretariacientifica2@geteccu.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life of patients (time frame: One year of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330846, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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