Biodegradable Stent Implantation in Biliary Benign Strictures.

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).

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Key information

Conditions

Biliary Tract Biliary Tract Diseases Constriction, Pathologic Digestive System Diseases Follow-Up Studies Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stenosis Stents

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lozano Blesa Universitary Hospital, Zaragoza, Aragon, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous placement of biodegradable biliary stents

Device

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.

Primary outcomes

Biliary duct patency: bilirubin alterations (> 2.2)

Time frame: 24 months

Biliary duct patency after stent implantation evaluating bilirubin alterations
Stent reabsorption: radiographic persistence of stent radiopaque marks

Time frame: 12 months

Radiography

Sponsors and collaborators

Lead sponsor

Group of Research in Minimally Invasive Techniques

Other

Registry information

Official study title

Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

Acronym: BiELLA

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2019
First posted: Oct 4, 2019
Registry last updated: Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed