Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
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.
Biliary Tract Neoplasms
Device: 6 mm Nitinol Zilver Stent
Device: 10 mm Nitinol Zilver Stent
Device: 10 mm Stainless Steel Wallstent
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction|
- Patency [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]Number of days of stent patency: The time to stent occlusion requiring re-intervention, death, loss to follow-up, or patients alive at study end without an occlusion (>= 6 months after placement).
- Closure or Blockage of the Stent (Occlusion) [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.
- Number of Days to Occlusion [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]
- Number of Deaths [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]
- Time to Death [ Time Frame: up to 32 months ] [ Designated as safety issue: No ]Overall Survival
|Study Start Date:||September 2003|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
Experimental: 6 mm Zilver
6 mm Nitinol Zilver Stent
|Device: 6 mm Nitinol Zilver Stent|
Experimental: 10 mm Zilver
10 mm Nitinol Zilver Stent
|Device: 10 mm Nitinol Zilver Stent|
Active Comparator: 10 mm Wallstent
10 mm Stainless Steel Wallstent
|Device: 10 mm Stainless Steel Wallstent|
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.