Biodegradable Stent Implantation in Biliary Benign Strictures. (BiELLA)

Group of Research in Minimally Invasive Techniques

Status: Completed

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

Treatments: Device: Percutaneous placement of biodegradable biliary stents

Study type: Observational

Funder types: Other

Identifiers

NCT04115696

GITMI-03

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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