Status:
COMPLETED
Paclitaxel Eluting Covered Metallic Stent for Unresectable Malignant Bile Duct Obstruction
Lead Sponsor:
Asan Medical Center
Conditions:
Bile Duct Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary goal is to determine stent patency and overall survival of the conventional covered self expandable metallic stent versus paclitaxel eluting covered self expandable metallic stent in unres...
Detailed Description
1.1 Self-expandable metallic stent (SEMS) Self-expandable metallic stent (SEMS) placement is a well-established and widely used treatment for patients with unresectable malignant biliary obstruction. ...
Eligibility Criteria
Inclusion
- Unresectable malignancy of the extrahepatic bile duct
- Age \>= 18 years and above
- Estimated life expectancy of more than 3 months
- ECOG performance status of 2 or lower
- Adequate bone marrow function
- WBCs \> 4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL
- Hemoglobin \>9.0 g/dL
- Platelets \> 100,000/µL
- Adequate kidney function (creatinine\<1.5 mg/dL)
- No serious medical or psychological condition that would preclude study treatment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion
- Age below 18 years
- Pregnancy
- Active alcohol or drug abuse
- Simultaneously participating in another investigational drug or device study
- Allergy to stainless steel or nitinol
- Allergy to paclitaxel
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00453076
Start Date
November 1 2006
End Date
June 1 2009
Last Update
June 11 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea