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N/A
19 Years
85 Years
Open (Enrolling)
Both
Obstructive Jaundice, Pancreatic Cancer

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Trial Information


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).

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:

Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Shyam Varadarajulu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Institutional Review Board

Study ID:

F100513025

NCT ID:

NCT01191814

Start Date:

July 2010

Completion Date:

July 2014

Related Keywords:

  • Obstructive Jaundice
  • Pancreatic Cancer
  • pancreatic cancer
  • obstructive jaundice
  • Obstructive jaundice secondary to pancreatic cancer
  • Jaundice
  • Jaundice, Obstructive
  • Pancreatic Neoplasms

Name

Location
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Vanderbilt University Nashville, Tennessee  37232-6305
Florida Hospital Orlando, Florida  32803
Eric Goldberg Baltimore, Maryland