Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
19 Years
N/A
Both
Obstructive Jaundice, Pancreatic Cancer
Trial Information
Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
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.
Inclusion Criteria
INCLUSION CRITERIA:
1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
2. Patients 19 yrs of age and older
3. Serum bilirubin > 2mg/dl
4. 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 CRITERIA:
1. Karnofsky score < 60
2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication
3. Tumor-related gastric outlet obstruction (vomiting and oral intake of < 1L/day)
4. Ongoing or planned neoadjuvant therapy
5. Cholangitis at presentation or coagulopathy needing reversal medication
6. Post-surgical anatomy
7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a
PTC or surgery).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complications related to stent dysfunction
Outcome Description:
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
Outcome Time Frame:
30 days
Safety Issue:
Yes
Principal Investigator
shyam varadarajulu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Florida Hospital Center for Interventional Endoscopy
Authority:
United States: Institutional Review Board
Study ID:
356090
NCT ID:
NCT01675908
Start Date:
July 2010
Completion Date:
July 2014
Related Keywords:
- Obstructive Jaundice
- Pancreatic Cancer
- Jaundice
- Jaundice, Obstructive
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Vanderbilt University | Nashville, Tennessee 37232-6305 |
| University of Maryland | Baltimore, Maryland 21201 |
| Florida Hospital | Orlando, Florida 32803 |
