Biodegradable Stent Implantation in Biliary Benign Strictures.

Stenosis Clinical Trial

— BiELLA  

Official title:

Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04115696
• Other study ID #: GITMI-03
• Status: Completed
• Start date: March 1, 2012
• Est. completion date: July 4, 2019

Study information

• Verified date: October 2019
• Source: Group of Research in Minimally Invasive Techniques
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 4, 2019
• Est. primary completion date: February 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Percutaneous 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.

Locations

Country	Name	City	State
Spain	Hospital Parc Tauli	Sabadell	Barcelona
Spain	Lozano Blesa Universitary Hospital	Zaragoza	Aragon

Sponsors (1)

Lead Sponsor	Collaborator
Group of Research in Minimally Invasive Techniques

Country where clinical trial is conducted

Spain, 

Outcome

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