Clincosm LogoSign in Get a demo

BiELLA: Biodegradable Stent Implantation in Biliary Benign Strictures.

Sponsor
Group of Research in Minimally Invasive Techniques (Other)
Overall Status
Completed
CT.gov ID
NCT04115696
Collaborator
(none)
150
Enrollment
2
Locations
88.1
Actual Duration (Months)
75
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Percutaneous placement of biodegradable biliary stents

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.
Actual Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Feb 3, 2018
Actual Study Completion Date :
Jul 4, 2019

Outcome Measures

Primary Outcome Measures

  1. Biliary duct patency: bilirubin alterations (> 2.2) [24 months]

    Biliary duct patency after stent implantation evaluating bilirubin alterations

  2. Stent reabsorption: radiographic persistence of stent radiopaque marks [12 months]

    Radiography

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lozano Blesa Universitary Hospital Zaragoza Aragon Spain 50009
2 Hospital Parc Tauli Sabadell Barcelona Spain 08208

Sponsors and Collaborators

  • Group of Research in Minimally Invasive Techniques

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Group of Research in Minimally Invasive Techniques
ClinicalTrials.gov Identifier:
NCT04115696
Other Study ID Numbers:
  • GITMI-03
First Posted:
Oct 4, 2019
Last Update Posted:
Oct 9, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Biliary Tract Diseases

Study Results

No Results Posted as of Oct 9, 2019