CompletedNot Applicable

Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.

Spain50 participantsStarted 2022-08-20

Plain-language summary

To assess safety and effectiveness in the long term of percutaneous insertion of Biodegradable (BD) Biliary Stents for the treatment of benign biliary strictures, in a single center experience.

Who can participate

Age range

18 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: * All patients over 18 years old attended in the interventional radiology department for the implantation of a biodegradable biliary stent (BBS: ELLA-CS, Hradec Kralove, Czech Republic), for each stenosis, by percutaneous technique. * Written informed consent given Exclusion Criteria: * Patients under 18 years old * Patients with post-liver transplant biliary strictures * Patients for whom no post-intervention follow-up data are available * Patients in whom malignancy is demonstrated as a cause of the stricture after stent placement.

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

Stent Primary Patency

Timeframe: Time from stent implantation to new intervention due to restenosis or occlusion detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests), assessed up to 60 months

Adverse Events

Timeframe: From stent implantation to completion of follow-up, up to 5 years

Trial details

NCT IDNCT05556668

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-11-05

View on ClinicalTrials.gov More Biliary Stricture trials