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

• 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.

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-15
• Study First Posted: 2012-01-19
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

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

Primary Outcome Measures

Name	Time	Method
Accumulative Patency Rate	6 month

Secondary Outcome Measures

Name	Time	Method
Accumulative Survival Rate	6 months
Possibility of Other Treatment after Obstruction	6 months
Complications	6 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