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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Biliary Neoplasms, Biliary Obstruction, Pancreatic Neoplasms

Intervention / Treatment
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* Device: Paclitaxel-eluting metal Stent
* Device: Covered Metal Stent


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-eluting metal Stent<br>Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea) | Device: Paclitaxel-eluting metal Stent<br>* Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP<br>|
| Active Comparator: Covered Metal Stent<br>ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea) | Device: Covered Metal Stent<br>* Insertion of ComVi Biliary Covered Stent using ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent migration | Stent migration is defined as an obvious dislodgement from the intended and original implant position and confirmed by radiography, CT, or ERCP. | 6 month | 
| Secondary stent insertion due to recurrent biliary obstruction |  | 6 month | 
| Mean survival |  | 6 month | 
| Adverse events |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting Biliary stent, Covered metalic stent