Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
Conditions
Obstructive Jaundice - Pancreatic Cancer
Conditions: official terms
Jaundice, Obstructive - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Stent Dysfunction Type: Procedure
Name: Complications Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
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).
Locations
Florida Hospital
Orlando, Florida, United States
Status: Recruiting
Contact: shyam varadarajulu, MD - 407-303-2570 - svaradarajulu@yahoo.com
University of Maryland
Baltimore, Maryland, United States
Status: Recruiting
Contact: Eric Goldberg, MD - egoldber@medicine.umaryland.edu
Vanderbilt University
Nashville, Tennessee, United States
Status: Recruiting
Contact: Patrick Yachimski, MD - patrick.yachimski@Vanderbilt.Edu
Start Date
July 2010
Completion Date
July 2015
Sponsors
Florida Hospital
Source
Florida Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page