Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - 85
Updated:10/8/2017
Start Date:July 2010
End Date:December 2019
Contact:Shyam Varadarajulu, MD
Email:svaradarajulu@uab.edu
Phone:2059347989

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A 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.

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.

Inclusion Criteria:

- 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 Criteria:

- 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).
We found this trial at
1
site
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Shyam Varadarajulu, MD
Phone: 407-303-2570
Florida Hospital Florida Hospital is one of the country
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mi
from
Orlando, FL
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