Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Obstructive Jaundice
• Interventions: Procedure: Stent Dysfunction; Procedure: Complications

• Registration Number: NCT01675908
• Lead Sponsor: AdventHealth

Brief 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.

Study Timeline

• Study Start: 2012-08-22
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Primary Completion: 2019-08-21
• Study Completion: 2019-08-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metal stent	Complications	Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
Metal stent	Stent Dysfunction	Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
Plastic Stent	Complications	At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
Plastic Stent	Stent Dysfunction	At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.

Primary Outcome Measures

Name	Time	Method
Complications related to stent dysfunction	30 days	Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.

Secondary Outcome Measures

Name	Time	Method
Procedural complications	30 days	This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States