Clinical trial · Interventional
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
Multicenter Prospective Randomized Controlled Trial of the Nitinol ZILVER Expandable Endoprosthesis in the Palliation of Extrahepatic Malignant Biliary Obstruction
NCT00196105CI-TRIAL-00005575completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Jaundice, Obstructive | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10 mm Nitinol Zilver Stent | Device | — | UNRESOLVED |
| 10 mm Stainless Steel Wallstent | Device | — | UNRESOLVED |
| 6 mm Nitinol Zilver Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 6 mm Zilver
- description
- 6 mm Nitinol Zilver Stent
- interventionNames
- Device: 6 mm Nitinol Zilver Stent
- type
- EXPERIMENTAL
- label
- 10 mm Zilver
- description
- 10 mm Nitinol Zilver Stent
- interventionNames
- Device: 10 mm Nitinol Zilver Stent
- type
- ACTIVE_COMPARATOR
- label
- 10 mm Wallstent
- description
- 10 mm Stainless Steel Wallstent
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLoew 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 of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc. 2009 Sep;70(3):445-53. doi: 10.1016/j.gie.2008.11.018. Epub 2009 May 30. PMID 19482279