Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)

April 7, 2017 updated by: Taewoong Medical Co., Ltd.

A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction

The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with malignant biliary obstruction, endoscopic placement of biliary stents offers similar technical success rates. Endoscopic retrograde cholangiography (ERCP)-guided stent placement has become the preferred approach to palliate malignant biliary obstruction. The major mechanisms of self-expandable metallic stent (SEMS) occlusion are tumor ingrowth, tumor overgrowth, and epithelial hyperplasia. These mechanisms provide the rationale for developing a drug-eluting stent in order to improve stent patency. Limited data exist regarding outcomes of paclitaxel-eluting stents in malignant biliary obstruction. This study is to prospectively compare the effectiveness and safety of paclitaxel-eluting covered metal stent and covered metal stent for the treatment of malignant biliary obstruction.

Study Type

Interventional

Enrollment (Actual)

106

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, 135-720
        • Gangnam Severance Hospital
    • Bokji-ro Busanjin-gu
      • Busan, Bokji-ro Busanjin-gu, Korea, Republic of, 633-165
        • Inje University Busan Paik Hospital
    • Haehak-ro Jongno-gu
      • Seoul, Haehak-ro Jongno-gu, Korea, Republic of, 110-744
        • Seoul National University Hospital
    • Inhang-ro Jung-gu
      • Incheon, Inhang-ro Jung-gu, Korea, Republic of, 400-711
        • In Ha University Hospital
    • Irwon-Dong, Gangnam-Gu
      • Seoul, Irwon-Dong, Gangnam-Gu, Korea, Republic of, 130-710
        • Samsung Medical Center

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than or equal to 19 years of age
  • Malignant mid or distal biliary obstruction
  • Unresectable cancer
  • Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
  • Patient willing to provide written informed consent and comply with follow-up requirements

Exclusion Criteria:

  • Patients who had undergone surgical biliary drainage
  • Severe bleeding disorder (e.g. coagulopathy)
  • Polypoid lesion or intra-abdominal abscess
  • Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel-eluting metal Stent
Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)
Device: Paclitaxel-eluting metal Stent
Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP
Active Comparator: Covered Metal Stent
ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)
Device: Covered Metal Stent
Insertion of ComVi Biliary Covered Stent using ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative stent patency during 6months after stent placement
Time Frame: 6 month
Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent migration
Time Frame: 6 month
Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.
6 month
Secondary stent insertion due to recurrent biliary obstruction
Time Frame: 6 month
6 month
Mean survival
Time Frame: 6 month
6 month
Adverse events
Time Frame: 6 month
6 month

Collaborators and Investigators

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

Sponsor

Taewoong Medical Co., Ltd.

Investigators

  • Study Chair: Dong Ki Lee, Ph.D MD, Gangnam Severance Hospital
  • Principal Investigator: Kyu Taek Lee, Ph.D MD, Samsung Medical Center
  • Principal Investigator: Sang Hyub Lee, Ph.D MD, Seoul National University Hospital
  • Principal Investigator: Don Haeng Lee, Ph.D MD, In Ha University Hospital
  • Principal Investigator: Jung Sik Choi, Ph.D MD, Inje University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

December 26, 2016

Study Completion (Actual)

December 26, 2016

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 29, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIRA-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

February 12, 2016

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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