N/A
N=241
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Biliary Tract Neoplasms · Pancreatic Neoplasms · Jaundice, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00196105 ↗Enrolled (actual)
241
Serious AEs
—
Results posted
Jan 2010
Primary outcome: Primary: Patency — 110; 125.5; 121 Days — p=.057
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 6 mm Nitinol Zilver Stent (Device); 10 mm Nitinol Zilver Stent (Device); 10 mm Stainless Steel Wallstent (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patency |
110; 125.5; 121 | .057 |
| PRIMARY Closure or Blockage of the Stent (Occlusion) |
25; 21; 19 | .04 sig |
| PRIMARY Number of Days to Occlusion |
115; 111; 103 | .16 |
| PRIMARY Number of Deaths |
4; 6; 2 | — |
| PRIMARY Time to Death |
132.6; 186; 170 | .32 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00196105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.