Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chro… (NCT04330846) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's Disease.
Spain40 participantsStarted 2022-11-29
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Asymptomatic patient.
* Stenosis length ≥ 10 cm.
* Presents with \> 2 stenoses.
* Severe coagulation disorders (platelets \< 70000; INR \> 1.8).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life of patients
Timeframe: One year of follow-up
Trial details
NCT IDNCT04330846
SponsorGrupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa