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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Biliary Stricture Malignant Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Paclitaxel ElutingCovered Metal Stent

Group Type EXPERIMENTAL

Biliary stent

Intervention Type DEVICE

palliative treatment for malignant patients

Covered Metal Stent

Group Type ACTIVE_COMPARATOR

Biliary stent

Intervention Type DEVICE

palliative treatment for malignant patients

Interventions

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Biliary stent

palliative treatment for malignant patients

Intervention Type DEVICE

Other Intervention Names

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Niti-S Mira-Cover Biliary Stent Niti-S Biliary Stent

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No