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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02460432

Enrollment

106

Registered

2015-06-02

Start date

2015-05-31

Completion date

2016-12-26

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms

Keywords

Drug-eluting Biliary stent, Covered metalic stent

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.

Interventions

DEVICEPaclitaxel-eluting metal Stent

Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP

DEVICECovered Metal Stent

Insertion of ComVi Biliary Covered Stent using ERCP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Stent migration	6 month	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	6 month	—
Mean survival	6 month	—
Adverse events	6 month	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026