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


N/A
21 Years
N/A
Not Enrolling
Both
Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patency

Outcome Description:

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).

Outcome Time Frame:

up to 32 months

Safety Issue:

No

Principal Investigator

Douglas Howell, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maine Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

03-MOZ

NCT ID:

NCT00196105

Start Date:

September 2003

Completion Date:

December 2006

Related Keywords:

  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms
  • Jaundice, Obstructive
  • Stents
  • Stent-graft
  • Minimally invasive
  • Biliary Tract Cancer
  • Pancreatic Cancer
  • Jaundice
  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms
  • Jaundice, Obstructive
  • Zilver
  • Biliary Tract Neoplasms
  • Neoplasms
  • Jaundice
  • Jaundice, Obstructive
  • Pancreatic Neoplasms

Name

Location

Maine Medical CenterPortland, Maine  04102