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

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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Diseases; Biliary Stricture; Obstructive Jaundice; Stents; Bile Duct Injury; Bile Duct Stricture
• Intervention / Treatment: Device: Percutaneous placement of biodegradable biliary stents

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Sabadell, Spain, 08208
    • Hospital Parc Tauli Sabadell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

50 patients with symptomatic benign biliary strictures from Parc Tauli University Hospital referral area and derived from other referring Hospitals treated in our center with a BBS

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	From stent implantation to completion of follow-up, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: Universitat Autonoma de Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): November 5, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pathological Conditions, Anatomical; Skin Manifestations; Bile Duct Diseases; Hyperbilirubinemia; Constriction, Pathologic; Cholestasis; Jaundice; Jaundice, Obstructive; Biliary Tract Diseases
• Other Study ID Numbers: CSPT_ECP_2020_600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No