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Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer


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

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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 UniversityNashville, Tennessee  37232-6305
University of MarylandBaltimore, Maryland  21201
Florida HospitalOrlando, Florida  32803