Biodegradable Stent Implantation in Biliary Benign Strictures.

Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04115696

Acronym

BiELLA

Enrollment

150

Registered

2019-10-04

Start date

2012-03-01

Completion date

2019-07-04

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract, Biliary Tract Diseases, Follow-Up Studies, Stenosis, Stents

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.

Interventions

DEVICEPercutaneous placement of biodegradable biliary stents

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026