Clinical trial NCT05556668: Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.
Official title: Role of Biodegradable Polydioxanone Biliary Stents for the Percutaneous Treatment of Benign Biliary Strictures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stricture
Biliary Tract Diseases
Bile Duct Stricture
Bile Duct Injury
Stents
Obstructive Jaundice
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2022-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stent Primary Patency
timeFrame: 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
measure: Adverse Events
timeFrame: From stent implantation to completion of follow-up, up to 5 years
Secondary outcomes:
measure: Technical Success
timeFrame: Immediate (during procedure)
measure: Length of Hospital Stay
timeFrame: nights from admission to perform the stent implantation to discharge of the patient from the hospital, assessed up to 365 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc Tauli Sabadell
Study officials:
affiliation: Corporació Universitaria Parc Tauli
name: Eva Criado-Paredes, MD
role: PRINCIPAL_INVESTIGATOR
References: