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

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ClinicalTrials.gov Identifier: NCT02460432
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Taewoong Medical Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Biliary Neoplasms Biliary Obstruction Pancreatic Neoplasms Device: Paclitaxel-eluting metal Stent Device: Covered Metal Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Actual Primary Completion Date : December 26, 2016
Actual Study Completion Date : December 26, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Secondary stent insertion due to recurrent biliary obstruction [ Time Frame: 6 month ]
  3. Mean survival [ Time Frame: 6 month ]
  4. Adverse events [ Time Frame: 6 month ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460432


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

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Responsible Party: Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02460432     History of Changes
Other Study ID Numbers: MIRA-003
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: February 12, 2016
Keywords provided by Taewoong Medical Co., Ltd.:
Drug-eluting Biliary stent
Covered metalic stent
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action