NCT01191814

Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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 as there will be better drainage of the obstructed biliary system with fewer adverse events.

Conditions

• Obstructive Jaundice
• Pancreatic Cancer

Interventions

Type	Name	Description
PROCEDURE	Metal stent	Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
PROCEDURE	Plastic stent	Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

Timeline

• Start date: 2010-07-01
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2010-08-31
• Last updated: 2023-07-12

Locations

1 site across 1 country: United States