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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Neoplasms Biliary Obstruction Pancreatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Paclitaxel-eluting metal Stent

Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)

Group Type EXPERIMENTAL

Paclitaxel-eluting metal Stent

Intervention Type DEVICE

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

Covered Metal Stent

ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)

Group Type ACTIVE_COMPARATOR

Covered Metal Stent

Intervention Type DEVICE

Insertion of ComVi Biliary Covered Stent using ERCP

Interventions

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Paclitaxel-eluting metal Stent

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

Intervention Type DEVICE

Covered Metal Stent

Insertion of ComVi Biliary Covered Stent using ERCP

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No