Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction

This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive jaundice.

This research is being done to determine if the new, FDA-cleared Zilver metal biliary stent is better than the conventional stents. The new Zilver stent may permit more accurate placement, may avoid some potential complications and last longer than the conventional stents. The study will also examine to find the best diameter of stent by comparing standard 10 mm stents to 6 mm Zilver stents.

Inclusion Criteria:

• Unresectable malignancy of the extrahepatic bile duct

Exclusion Criteria:

• Age below 21 years
• Pregnancy
• Active alcohol or drug abuse
• Simultaneously participating in another investigational drug or device study.
• Allergy to stainless steel or nitinol
• Active cholangitis
• Brachytherapy
• Unable or unwilling to comply with follow up