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.
The HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
66
Multi-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.
Time frame: 6 Month
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