Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent

A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.

Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Inclusion Criteria:

• Patient who submitted a written informed consent for the this trial, and 18 ~ 90 years old
• Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
• Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
• Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
• Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)

Exclusion Criteria:

• Patient who previously had surgical biliary drainage
• Patient who carrying bleeding disorder
• Patient who have combined Hilar and/or intra-hepatic duct cancer
• Patient who is improper to endoscopic treatment