Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive

Intervention / Treatment
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* Device: 6 mm Nitinol Zilver Stent
* Device: 10 mm Nitinol Zilver Stent
* Device: 10 mm Stainless Steel Wallstent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 mm Zilver<br>6 mm Nitinol Zilver Stent | Device: 6 mm Nitinol Zilver Stent<br> <br> |
| Experimental: 10 mm Zilver<br>10 mm Nitinol Zilver Stent | Device: 10 mm Nitinol Zilver Stent<br> <br> |
| Active Comparator: 10 mm Wallstent<br>10 mm Stainless Steel Wallstent | Device: 10 mm Stainless Steel Wallstent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of Days to Occlusion |  | up to 32 months | 
| Number of Deaths |  | up to 32 months | 
| Time to Death | Overall Survival | up to 32 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stents, Stent-graft, Minimally invasive, Biliary Tract Cancer, Pancreatic Cancer, Jaundice, Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive, Zilver