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

To Evaluate Patency of the Viaduct Stent in Comparison to Metal Stents Clinical Trial

— VIADUCT  

Official title:

Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction. A Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01063634
• Other study ID #: VIADUCT
• Status: Recruiting
• Phase: N/A
• First received: February 4, 2010
• Last updated: February 4, 2010
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2010
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: Karel Caca, Prof. Dr.
• Phone: +49-7141-9967201
• Email: karel.caca[@]kliniken-lb.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (3)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH	Klinikum Ludwigshafen, Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Secondary	time to stent obstruction		1 year	No