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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

About this trial

This is an interventional treatment trial for Biliary Neoplasms focused on measuring Drug-eluting Biliary stent, Covered metalic stent

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT02460432

First Posted

May 26, 2015

Last Updated

April 7, 2017

Sponsor

Taewoong Medical Co., Ltd.

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

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: