NCT04115696

Biodegradable Stent Implantation in Biliary Benign Strictures.

Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Group of Research in Minimally Invasive Techniques · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2018-02-03
• Completion: 2019-07-04
• First posted: 2019-10-04
• Last updated: 2019-10-09

Locations

2 sites across 1 country: Spain