The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.

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.

Inclusion Criteria: * 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 Clinical symptoms including (e.g., cholangitis, jaundice, pruritus, pale stools, and/or dark urine) Biochemical evidence (Tbili \> 3mg/dL) High quality imaging (e.g., ultrasound, CT, MRCP, or ERCP) ≥ 18 years of age Willing and able to provide informed consent Exclusion Criteria: * Participation in another investigational study within 90 days prior to consent Intrahepatic metastases that extensively involve both lobes of the liver Patients with a distal malignant biliary obstruction due to potential resectable disease Strictures that could not be traversed by the delivery system Perforation of any duct within the biliary tree Presence of a biliary self-expanding metal stent (SEMS), esophageal stent, or duodenal stent Active viral hepatitis Life expectancy of \< 3 months Patient has undergone (within 30 days prior to enrollment) or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources Unwilling or unable to comply with the follow-up schedule