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Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00196105
First received: September 12, 2005
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Biliary Tract Neoplasms
Pancreatic Neoplasms
Jaundice, Obstructive
 Device: 6 mm Nitinol Zilver Stent
Device: 10 mm Nitinol Zilver Stent
Device: 10 mm Stainless Steel Wallstent

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • 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


Enrollment: 241
Study Start Date: September 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196105

Locations
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Douglas Howell, M.D. Maine Medical Center
  More Information

Publications:

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00196105     History of Changes
Other Study ID Numbers: 03-MOZ
Study First Received: September 12, 2005
Results First Received: September 25, 2009
Last Updated: September 28, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada

Keywords provided by Cook:
Stents
Stent-graft
Minimally invasive
Biliary Tract Cancer
Pancreatic Cancer
 Jaundice
Biliary Tract Neoplasms
Pancreatic Neoplasms
Jaundice, Obstructive
Zilver

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Neoplasms
Jaundice
Jaundice, Obstructive
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
 Digestive System Diseases
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 16, 2012