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

Corporacion Parc Tauli50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Biliary Stricture Biliary Tract Diseases Bile Duct Stricture Bile Duct Injury Stents Obstructive Jaundice

Interventions

Percutaneous placement of biodegradable biliary stentsDEVICE

Benign biliary strictures treated with polydioxanone (PPDX) stents (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography. Before stent implantation, balloon bilioplasty is be performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Parc Tauli Sabadell

Sabadell, Spain

Outcomes

Primary Outcomes

Stent Primary Patency

Time until new intervention due to re-stenosis or occlusion (detected by clinical signs and symptoms and confirmed by blood-test disturbances and/or imaging tests)

Time frame: 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

Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications.

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

Secondary Outcomes

Technical Success

To correctly deploy a biodegradable stent using a percutaneous approach covering the stricture with a residual stenosis of less than 30% of the lumen, and correct flow of contrast through it into the intestinal lumen

Time frame: Immediate (during procedure)

Length of Hospital Stay

number of days that patients spend in hospital to have the stent inserted, including a 24-48h control cholangiogram

Time frame: nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.