UnknownNot Applicable

Long-term Study of Endoscopic Treatment of Stenosis in Crohn´s Disease

Spain80 participantsStarted 2022-12-19

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. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications. The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis \> 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros). Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial. The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis \< 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.

Who can participate

Age range

18 Years – 75 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: * Age18-75. * CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy). * Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic. * Intestinal occlusion or sub-occlusion symptomatology. * Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale). * Stenosis length \< 10 cm. * Maximum 2 stenoses. * Informed consent of patient. Exclusion Criteria: * No informed consent of patient. * Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area. * Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic. * Pregnancy or lactation. * Any clinical condition that prevents the performance of endoscopy. * Stenosis inaccessible by colonoscopy. * No obstructive symptoms. * Stenosis length ≥ 10 cm. * Presenting more than 2 stenoses. * Serious coagulation disorder (platelets \< 70000; INR \> 1.5)

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

Percentage of surgery-free patients post-treatment

Timeframe: end of long-term follow up (median 7 years post-treatment)

Trial details

NCT IDNCT06036680

SponsorHospital Mutua de Terrassa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-15

View on ClinicalTrials.gov More Crohn Disease trials