Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
up to 32 months
Douglas Howell, M.D.
Maine Medical Center
United States: Food and Drug Administration
|Maine Medical Center||Portland, Maine 04102|