Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Cook Group

Status: Completed

Conditions: Jaundice, Obstructive; Biliary Tract Neoplasms; Pancreatic Neoplasms

Treatments: Device: 10 mm Nitinol Zilver Stent; Device: 10 mm Stainless Steel Wallstent; Device: 6 mm Nitinol Zilver Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196105

03-MOZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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241 participants in 3 patient groups

6 mm Zilver

Experimental group

Description:

6 mm Nitinol Zilver Stent

Treatment:

Device: 6 mm Nitinol Zilver Stent

10 mm Zilver

Experimental group

Description:

10 mm Nitinol Zilver Stent

Treatment:

Device: 10 mm Nitinol Zilver Stent

10 mm Wallstent

Active Comparator group

Description:

10 mm Stainless Steel Wallstent

Treatment:

Device: 10 mm Stainless Steel Wallstent