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Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent

Not Applicable
Completed
Conditions
Malignant Neoplasms
Biliary Stricture
Interventions
Device: Biliary stent
Registration Number
NCT01512563
Lead Sponsor
Taewoong Medical Co., Ltd.
Brief Summary

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Detailed Description

Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
106
Inclusion Criteria
  • Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
  • Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility
Exclusion Criteria
  • Patient who have life expectancy under 3 months
  • Patient who have severe metastasis of Liver or whole body
  • Patient who previously had surgical biliary drainage

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Paclitaxel ElutingCovered Metal StentBiliary stent-
Covered Metal StentBiliary stent-
Primary Outcome Measures
NameTimeMethod
Accumulative Patency Rate6 month
Secondary Outcome Measures
NameTimeMethod
Complications6 months
Accumulative Survival Rate6 months
Possibility of Other Treatment after Obstruction6 months

Trial Locations

Locations (3)

Soon Chun Hyang University Hospital Cheonan

🇰🇷

Cheonan, Korea, Republic of

Catholic University of Daegu School of Medicine

🇰🇷

Daegu, Korea, Republic of

Kangnam Severance Hospital

🇰🇷

Seoul, Korea, Republic of

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