Trial Information

A Prospective Randomized Trial of Plastic vs. Covered Metal vs. Uncovered Metal Biliary Stents for the Management of Malignant Biliary Obstruction

Malignant biliary obstruction can result from extrinsic processes, such as proximal
pancreatic ductal adenocarcinoma or metastatic lesions, or from intrinsic lesions such as
cholangiocarcinoma. Malignant biliary obstruction is typically treated endoscopically with
placement of either plastic (polyethylene) or metal biliary stents. Metal stents have a
wider diameter than plastic stents, and have been shown to have higher patency rates, but
are also 15-40 times the cost of plastic stents. Metal stents with a polymer coating have
been developed to prevent tumor ingrowth into the stent, which can lead to stent occlusion.
Cost analysis has demonstrated an advantage to the use of metal stents in patients with
unresectable disease, or who may achieve operable status following neoadjuvant chemotherapy,
while either plastic stents or metal stents are used when patients are deemed to have a
surgically resectable lesion. Patient's determined to have resectable, or borderline
resectable malignancy (those who may achieve resectability status following neoadjuvant
chemotherapy) will receive either plastic, uncovered metal, or covered metal stents in a
randomized fashion, while patients determined to have surgically unresectable malignancy
will randomly receive either covered or uncovered metal biliary stents. The primary aim of
this study is to prospectively evaluate stent occlusion rates in patients presenting with
malignant biliary obstruction. Secondary aims of the study will include a cost analysis of
each stent type, rate of hospital admission following stent placement, days off of
chemotherapy due to procedural complication, and rate of acute cholecystitis associated with
stent placement.