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 HANAROSTENT® Multi-Hole™ Biliary Stent is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

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