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

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT01063634

VIADUCT

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%