Status:
COMPLETED
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
Lead Sponsor:
AdventHealth
Collaborating Sponsors:
University of Virginia
Conditions:
Obstructive Jaundice
Pancreatic Cancer
Eligibility:
All Genders
19-85 years
Phase:
NA
Brief 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-...
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-...
Eligibility Criteria
Inclusion
- Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
- Patients 19 yrs of age and older
- Serum bilirubin \> 2mg/dl
- CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).
Exclusion
- Karnofsky score \< 60
- Prior (ERCP or PTC) attempts at biliary decompression for the same indication
- Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
- Ongoing or planned neoadjuvant therapy
- Cholangitis at presentation or coagulopathy needing reversal medication
- Post-surgical anatomy
- Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
- Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01191814
Start Date
July 1 2010
End Date
October 13 2022
Last Update
July 12 2023
Active Locations (1)
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1
AdventHealth
Orlando, Florida, United States, 32814