Spots Global Cancer Trial Database for Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

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Trial Identification

Brief Title: Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

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

Study ID: NCT00196105

Conditions

Biliary Tract Neoplasms

Pancreatic Neoplasms

Jaundice, Obstructive

Interventions

6 mm Nitinol Zilver Stent

10 mm Nitinol Zilver Stent

10 mm Stainless Steel Wallstent

Study Description

Brief Summary: 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.

Detailed Description: 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.