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

Corporacion Parc Tauli

Status: Completed

Conditions: Bile Duct Injury; Stents; Biliary Stricture; Bile Duct Stricture; Obstructive Jaundice; Biliary Tract Diseases

Treatments: Device: Percutaneous placement of biodegradable biliary stents

Study type: Observational

Funder types: Other

Identifiers

NCT05556668

CSPT_ECP_2020_600

Details and patient eligibility

About

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.

Full description

This is an observational study (retrospective analysis on a prospective database) of patients that have been implanted a biodegradable stent in the biliary tree to treat benign stenosis.

From march 2011 until May 2020, a prospective collection of clinical data has been conducted in patients with symptomatic benign biliary strictures treated biodegradable polydioxanone stents. A strict follow-up protocol has been carried out according to standard practice (at 2, 4, 6 months and every 6 months up to 5 years). Once the follow-up is completed, the collected data will be analyzed, assessing the long term effectiveness and safety, but also other variables related to stent implantation and impact on patient's quality of life.

A subgroup analysis of anastomotic biliary strictures will be performed.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.