The objective of this study is to demonstrate clinical safety and performance of the HANAROSTENT® Multi-Hole™ Biliary Stent for the palliative treatment of malignant biliary obstruction.
Suspected or confirmed malignant non-hilar extrahepatic biliary obstruction including any of the following measures of biliary obstruction or patients undergoing neoadjuvant cancer treatment (chemotherapy and/or radiation) for malignant biliary obstruction
Participation in another investigational study within 90 days prior to consent
Single group
Biliary Stent for the Palliative Treatment of Malignant Biliary Obstruction
DeviceMulti-hole anti-migration stent for biliary strictures produced by malignant neoplasms
Primary Endpoints
Primary Outcome Measures 1\. Clinical palliation of biliary obstruction maintenance of total bilirubin (Tbili) at 1-month follow-up \< 3 mg/dL OR Tbili reduction by \> 30% if the baseline value is \> 3 mg/dL and absence of acute cholangitis AND absence of stent-related re-intervention until death, surgery, completion of data collection at 6-month follow-up visit, or withdrawal, whichever occurs first.
Stent Repositioning
Ability to successfully reposition or remove the stent, if required, at initial placement without clinically significant complications or technical difficulties
Stent Deployment
Stent Deployment Ability to deploy the stent in satisfactory position \[During the procedure\]
Symptoms
Symptoms of biliary obstruction (including jaundice, pruritus, right upper quadrant pain, fever, nausea, vomiting, and dark urine) at 1-, 3-, and 6-month follow-up visits and Tbili at 1-, 3-, and 6-month follow-up visits
Stent Patency
Stent patency rate at 1-, 3-, and 6-months post stent placement 6. Stent Occlusion or migration
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Olympus Corporation of the Americas
Lead sponsor
Mayo Clinic
Collaborator
M.I.Tech Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
