Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr
plastic stents. When compared to plastic stents, randomized trials have shown longer patency
and fewer stent-related complications for CSEMS. The investigators hypothesize that
placement of CSEMS would be a better treatment option for preoperative biliary decompression
in patients with pancreatic cancer.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complications related to stent dysfunction
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
shyam varadarajulu, MD
Florida Hospital Center for Interventional Endoscopy
United States: Institutional Review Board
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|University of Maryland||Baltimore, Maryland 21201|
|Florida Hospital||Orlando, Florida 32803|