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Clinical Trials/NCT01675908
NCT01675908
Completed
Not Applicable

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

AdventHealth1 site in 1 country46 target enrollmentAugust 22, 2012
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ConditionsObstructive JaundicePancreatic Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Jaundice
Sponsor
AdventHealth
Enrollment
46
Locations
1
Primary Endpoint
Complications related to stent dysfunction
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 22, 2012
End Date
August 21, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Complications related to stent dysfunction

Time Frame: 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 Outcomes

  • Procedural complications(30 days)

Study Sites (1)

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