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

Completed

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

• Registration Number: NCT05556668
• Lead Sponsor: Corporacion Parc Tauli

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-20
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Primary Completion: 2022-11-05
• Study Completion: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events	From stent implantation to completion of follow-up, up to 5 years	Major and minor complications. The Clavien-Dindo classification will be used for grading the severity of complications.
Stent Primary Patency	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	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)

Secondary Outcome Measures

Name	Time	Method
Technical Success	Immediate (during procedure)	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
Length of Hospital Stay	nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days	number of days that patients spend in hospital to have the stent inserted, including a 24-48h control cholangiogram

Trial Locations

Locations (1)

Hospital Parc Tauli Sabadell; 🇪🇸 Sabadell, Spain