Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic 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

TERMINATED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-04-23

Brief Summary

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Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

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Detailed Description

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Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent\_ComVi type)in their patency rate and safety at the 6 months after stenting.

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 Eluting Covered 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 II Biliary Stent Niti-S Biliary Stent_ComVi type

Eligibility Criteria

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Inclusion Criteria

* Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
* Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
* Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
* Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
* Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%)

Exclusion Criteria

* Patient who previously had surgical biliary drainage
* Patient who carrying bleeding disorder
* Patient who have combined Hilar and/or intra-hepatic duct cancer
* Patient who is improper to endoscopic treatment

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No