Biodegradable Stent Implantation in Biliary Benign Strictures.

Group of Research in Minimally Invasive Techniques150 enrolled

Overview

Spanish registry of resorbable stent implantation in biliary benign strictures. This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain). A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree. Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Biliary Tract Biliary Tract Diseases Stenosis Follow-Up Studies Stents

Interventions

The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Older than 18 years-old * Informed consent * Non-lithiasic chronic bening single or multiple stenosis * Possibility of follow-up plus 1 year Exclusion Criteria: * Under 18 years old * Unsigned consent * Non treatable coagulopathy * Acute signs of infection * Diagnosis of neoplasia

Locations (2)

Lozano Blesa Universitary Hospital

Zaragoza, Aragon, Spain

Hospital Parc Tauli

Sabadell, Barcelona, Spain

Outcomes

Primary Outcomes

Biliary duct patency: bilirubin alterations (> 2.2)

Biliary duct patency after stent implantation evaluating bilirubin alterations

Time frame: 24 months

Stent reabsorption: radiographic persistence of stent radiopaque marks

Radiography

Time frame: 12 months