Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction

The purpose of this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.

Inclusion Criteria:

• distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice
• 18 years of age or older
• serum bilirubin > 2mg/dL

Exclusion Criteria:

• prior endoscopic or percutaneous biliary drainage
• post-surgical anatomy
• primary site of biliary obstruction involving the common hepatic duct or hilum
• tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation