Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Not Applicable

Completed

• Conditions: Biliary Tract Neoplasms; Pancreatic Neoplasms; Jaundice, Obstructive
• Interventions: Device: 6 mm Nitinol Zilver Stent; Device: 10 mm Nitinol Zilver Stent; Device: 10 mm Stainless Steel Wallstent

• Registration Number: NCT00196105
• Lead Sponsor: Cook Group Incorporated

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.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Results First Submitted: 2009-09-25
• Results First Submitted QC: 2010-01-11
• Results First Posted: 2010-01-12
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-28
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 mm Zilver	6 mm Nitinol Zilver Stent	6 mm Nitinol Zilver Stent
10 mm Zilver	10 mm Nitinol Zilver Stent	10 mm Nitinol Zilver Stent
10 mm Wallstent	10 mm Stainless Steel Wallstent	10 mm Stainless Steel Wallstent

Primary Outcome Measures

Name	Time	Method
Patency	up to 32 months	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)	up to 32 months	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	up to 32 months
Number of Deaths	up to 32 months
Time to Death	up to 32 months	Overall Survival

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States