Biodegradable Stent Implantation in Biliary Benign Strictures. (BiELLA)

October 7, 2019 updated by: Group of Research in Minimally Invasive Techniques

Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Aragon
      • Zaragoza, Aragon, Spain, 50009
        • Lozano Blesa Universitary Hospital
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

120- 150 patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Group of Research in Minimally Invasive Techniques

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

February 3, 2018

Study Completion (ACTUAL)

July 4, 2019

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

October 2, 2019

First Posted (ACTUAL)

October 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GITMI-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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