RecruitingNot ApplicableNCT04330846

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)


Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Enrollment

40 participants

Start Date

Nov 29, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different treatments for people with Crohn's disease who have developed a new narrowing (stenosis) in their intestine — a fibrous blockage that makes it hard for food and waste to pass through. Researchers are comparing endoscopic (non-surgical) treatments, such as dilation or stenting, against surgery to find out which works best. **You may be eligible if...** - You are between 18 and 80 years old - You have Crohn's disease with a new fibrous narrowing of the intestine confirmed by imaging and colonoscopy - Your narrowing causes symptoms of intestinal blockage - Your narrowing is accessible by colonoscopy and is less than 10 cm long - You have no more than 2 narrowings - Standard medical treatments have not resolved your problem **You may NOT be eligible if...** - Your narrowing is complicated by an abscess, fistula, or severe active inflammation - You have had a stent or dilation for this narrowing within the last year - You are pregnant or breastfeeding - You have severe blood clotting problems - Your narrowing cannot be reached by colonoscopy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical resection

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


Locations(16)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Althaia, xarxa assistencial universitaria de Manresa

Manresa, Barcelona, Spain

Consorci Corporació Sanitària Parc Taulí

Sabadell, Barcelona, Spain

Hospital Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario de Cáceres

Cáceres, Spain

Clínica Girona

Girona, Spain

Hospital Josep Trueta

Girona, Spain

Hospital de Inca

Inca, Spain

Hospital Universitari Arnau de Vilanova

Lleida, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital de Terrassa

Terrassa, Spain

Hospital Clínico de Valencia

Valencia, Spain

Hospital Universitari La Fe

Valencia, Spain

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NCT04330846


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