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NCT04330846Recruiting

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

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)

Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
25 Mar 2020
Start date
29 Nov 2022
Primary completion date
1 Apr 2026
Lead sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
NCT number
NCT04330846

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 29 Nov 2022 to the primary completion date, 1 Apr 2026
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with known stenosis previously treated with stenting and/or dilation performed \< 1 year before the date of inclusion.
  • Any clinical situation that prevents the performance of endoscopy or surgery.

Other illness

  • Complicated stenosis with abscess, fistula or significant activity associated with CD not limited to the area of the stenosis.

Lab values

  • Severe coagulation disorders (platelets \< 70000; INR \> 1.8).

Other

  • No informed consent from the patient.
  • Pregnancy or lactation.
  • Stenosis not accessible by endoscopy.
  • Asymptomatic patient.
  • Stenosis length ≥ 10 cm.
  • Presents with \> 2 stenoses.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Hospital Universitario De Caceres
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CaceresSpainRecruiting
Clínica Girona
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GironaSpainNot yet recruiting
Hospital Josep Trueta
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GironaSpainNot yet recruiting
Hospital de Inca
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IncaSpainNot yet recruiting
Hospital Universitario de Bellvitge
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L'Hospitalet de LlobregatSpainNot yet recruiting
Hospital Universitari Arnau de Vilanova
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LleidaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
Hospital Universitario La Paz
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MadridSpainNot yet recruiting
ALTHAIA, Xarxa Assistencial Universitaria de Manresa.
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ManresaSpainNot yet recruiting
Consorci Corporació Sanitària Parc Taulí
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SabadellSpainRecruiting
Hospital Moisès Broggi
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Sant Joan DespíSpainNot yet recruiting
Hospital de Terrassa
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TerrassaSpainNot yet recruiting
Hospital Mutua de Terrassa
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TerrassaSpainRecruiting
Hospital Clínico de Valencia
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ValenciaSpainNot yet recruiting
Hospital Universitari La Fe
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ValenciaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.