Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
Primary Purpose
Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel-eluting metal Stent
Covered Metal Stent
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Neoplasms focused on measuring Drug-eluting Biliary stent, Covered metalic stent
Eligibility 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.
Sites / Locations
- Inje University Busan Paik Hospital
- Seoul National University Hospital
- In Ha University Hospital
- Samsung Medical Center
- Gangnam Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paclitaxel-eluting metal Stent
Covered Metal Stent
Arm Description
Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)
ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)
Outcomes
Primary Outcome Measures
Cumulative stent patency during 6months after stent placement
Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.
Secondary Outcome Measures
Stent migration
Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.
Secondary stent insertion due to recurrent biliary obstruction
Mean survival
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02460432
Brief Title
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 26, 2016 (Actual)
Study Completion Date
December 26, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taewoong Medical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms
Keywords
Drug-eluting Biliary stent, Covered metalic stent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-eluting metal Stent
Arm Type
Experimental
Arm Description
Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)
Arm Title
Covered Metal Stent
Arm Type
Active Comparator
Arm Description
ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting metal Stent
Intervention Description
Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP
Intervention Type
Device
Intervention Name(s)
Covered Metal Stent
Intervention Description
Insertion of ComVi Biliary Covered Stent using ERCP
Primary Outcome Measure Information:
Title
Cumulative stent patency during 6months after stent placement
Description
Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Stent migration
Description
Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP.
Time Frame
6 month
Title
Secondary stent insertion due to recurrent biliary obstruction
Time Frame
6 month
Title
Mean survival
Time Frame
6 month
Title
Adverse events
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ki Lee, Ph.D MD
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kyu Taek Lee, Ph.D MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Hyub Lee, Ph.D MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Don Haeng Lee, Ph.D MD
Organizational Affiliation
In Ha University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Sik Choi, Ph.D MD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
State/Province
Bokji-ro Busanjin-gu
ZIP/Postal Code
633-165
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Haehak-ro Jongno-gu
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
In Ha University Hospital
City
Incheon
State/Province
Inhang-ro Jung-gu
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-Dong, Gangnam-Gu
ZIP/Postal Code
130-710
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
February 12, 2016
Citations:
PubMed Identifier
30414164
Citation
Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.
Results Reference
derived
Learn more about this trial
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
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