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

March 9, 2020 updated by: Jong Taek, Lee

A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
    • In Chun
      • Incheon, In Chun, Korea, Republic of, 400-711
        • In Ha University Hospital
    • Seoul
      • Kangnam, Seoul, Korea, Republic of, 135-720
        • Kangnam Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Covered Metal Stent
Device: biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover II Biliary Stent
  • Niti-S Biliary Stent_ComVi type
Experimental: Paclitaxel Eluting Covered Metal Stent
Device: biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover II Biliary Stent
  • Niti-S Biliary Stent_ComVi type

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accumulative Patency Rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Accumulative Survival Rate
Time Frame: 6 months
6 months
Possibility of Other Treatment after Obstruction
Time Frame: 6 months
6 months
Stent migration rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jong Taek, Lee

Investigators

  • Study Chair: Dong Ki Lee, Ph.D, Kangnam Severance Hospital
  • Principal Investigator: Mung Whan Kim, Ph.D, Asan Medical Center
  • Principal Investigator: Don Haeng Lee, Ph.D, Inha University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

April 18, 2013

Study Completion (Actual)

April 23, 2013

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRA-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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