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

Taewoong Medical Co., Ltd.106 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

106

Conditions

Biliary Neoplasms Biliary Obstruction Pancreatic Neoplasms

Interventions

Paclitaxel-eluting metal StentDEVICE

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

Covered Metal StentDEVICE

Insertion of ComVi Biliary Covered Stent using ERCP

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (5)

Inje University Busan Paik Hospital

Busan, Bokji-ro Busanjin-gu, South Korea

Seoul National University Hospital

Seoul, Haehak-ro Jongno-gu, South Korea

In Ha University Hospital

Incheon, Inhang-ro Jung-gu, South Korea

Samsung Medical Center

Seoul, Irwon-Dong, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

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.

Time frame: 6 month

Secondary Outcomes

Stent migration

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

Secondary stent insertion due to recurrent biliary obstruction

Time frame: 6 month

Mean survival

Time frame: 6 month

Adverse events

Time frame: 6 month

Data from ClinicalTrials.gov

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