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

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05556668
• Other study ID #: CSPT_ECP_2020_600
• Status: Completed
• Start date: August 20, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 20, 2022
• Est. primary completion date: November 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bile Duct Injury
• Bile Duct Stricture
• Biliary Stricture
• Biliary Tract Diseases
• Cholestasis
• Constriction, Pathologic
• Jaundice
• Jaundice, Obstructive
• Obstructive Jaundice
• Stents

Intervention

Device:
• Percutaneous placement of biodegradable biliary stents
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.

Locations

Country	Name	City	State
Spain	Hospital Parc Tauli Sabadell	Sabadell

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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