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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biliary Stricture, Biliary Tract Diseases, Bile Duct Stricture, Bile Duct Injury, Stents, Obstructive Jaundice

Intervention / Treatment
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* Device: Percutaneous placement of biodegradable biliary stents


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 |