Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Inclusion Criteria:

• Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
• Bile duct or gallbladder cancer invading CBD or distal CHD
• Pancreatic cancer with mid or distal CBD invasion
• Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
• First attempt of endoscopic biliary metallic stenting
• Negative history of biliary tract surgery
• Life expectancy at least longer than 4 months (Karnofsky score >60%)

Exclusion Criteria:

• Ampullary cancer
• Klatskin tumor
• Combined intrahepatic bile duct cancer
• Patient with hemobilia
• Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days