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 range18 Years

SexALL

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.

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