Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction

• Conditions: To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents

• Registration Number: NCT01063634
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Brief Summary

This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Last Update Submitted: 2010-02-04
• Study First Posted: 2010-02-05
• Last Update Posted: 2010-02-05
• Primary Completion: 2011-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• histologically proven malignant biliary stenosis
• signs of biliary obstruction
• informed consent

Exclusion Criteria

• age under 18
• Operations like Roux-Y, biliodigestive Anastomosis, BII
• life expectancy less than 3 months
• Karnfosky index less than 60%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany