NCT01675908

Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Detailed description

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.

Conditions

• Obstructive Jaundice
• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Stent Dysfunction	Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
PROCEDURE	Complications	Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

Timeline

• Start date: 2012-08-22
• Primary completion: 2019-08-21
• Completion: 2019-08-21
• First posted: 2012-08-30
• Last updated: 2022-03-03

Locations

1 site across 1 country: United States