Biodegradable Stent Implantation in Biliary Benign Strictures.

Completed

• Conditions: Stenosis; Follow-Up Studies; Stents; Biliary Tract; Biliary Tract Diseases

• Registration Number: NCT04115696
• Lead Sponsor: Group of Research in Minimally Invasive Techniques

Brief Summary

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).

Detailed Description

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 Timeline

• Study Start: 2012-03-01
• Primary Completion: 2018-02-03
• Study First Submitted: 2018-09-12
• Study Completion: 2019-07-04
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biliary duct patency: bilirubin alterations (> 2.2)	24 months	Biliary duct patency after stent implantation evaluating bilirubin alterations
Stent reabsorption: radiographic persistence of stent radiopaque marks	12 months	Radiography

Trial Locations

Locations (2)

Lozano Blesa Universitary Hospital; 🇪🇸 Zaragoza, Aragon, Spain

Hospital Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain