Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196105
• Other study ID #: 03-MOZ
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 28, 2011
• Start date: September 2003
• Est. completion date: December 2006

Study information

• Verified date: September 2011
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Jaundice
• Jaundice, Obstructive
• Neoplasms
• Pancreatic Neoplasms

Intervention

Device:
• 6 mm Nitinol Zilver Stent

• 10 mm Nitinol Zilver Stent

• 10 mm Stainless Steel Wallstent

Locations

Country	Name	City	State
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

References & Publications (1)

Loew BJ, Howell DA, Sanders MK, Desilets DJ, Kortan PP, May GR, Shah RJ, Chen YK, Parsons WG, Hawes RH, Cotton PB, Slivka AA, Ahmad J, Lehman GA, Sherman S, Neuhaus H, Schumacher BM. Comparative performance of uncoated, self-expanding metal biliary stents — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency	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	No
Primary	Closure or Blockage of the Stent (Occlusion)	Biliary stents may become closed or blocked. This is also termed "Occlusion." Data for this outcome measure involve stent occlusions that required re-intervention.	up to 32 months	No
Primary	Number of Days to Occlusion		up to 32 months	No
Primary	Number of Deaths		up to 32 months	No
Primary	Time to Death	Overall Survival	up to 32 months	No