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

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

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.

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%