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

NCT05556668 | Completed

• 1 other identifier: CSPT_ECP_2020_600
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Technical Success

  Immediate (during procedure)

• 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

Interventions

Percutaneous placement of biodegradable biliary stents DEVICE

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• Universitat Autonoma de Barcelona: collaborator

Study Sites (1)

Hospital Parc Tauli Sabadell

Sabadell, 08208, Spain

Location

MeSH Terms

Conditions

Biliary Tract Diseases; Jaundice, Obstructive

Condition Hierarchy (Ancestors)

Digestive System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Eva Criado-Paredes, MD

  Corporació Universitaria Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 27, 2022
• Study Start: August 20, 2022
• Primary Completion: November 5, 2022
• Study Completion: December 20, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

ES (1)