Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01191814
First received: August 12, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Obstructive Jaundice
Pancreatic Cancer
Procedure: Metal stent placement in the bile duct
Procedure: Plastic stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Trial COmparing Covered Metal and Plastic Stnets for Preoperative Biliary Decompression in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Complications related to stent dysfunction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)


Secondary Outcome Measures:
  • Procedural complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.


Estimated Enrollment: 84
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metal stent
Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents
Procedure: Metal stent placement in the bile duct
At ERCP, fully covered metal stent will be placed in the bile duct.
Active Comparator: Plastic Stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct
Procedure: Plastic stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191814

Contacts
Contact: Shyam Varadarajulu, MD 2059347989 svaradarajulu@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Shyam Varadarajulu, MD    205-934-7989      
Principal Investigator: Shyam Varadarajulu, MD         
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32814
Contact: Shyam Varadarajulu, MD    407-303-2570      
Contact: Amy Logue, RN       amy.logue@flhosp.org   
Principal Investigator: Shyam Varadarajulu, MD         
United States, Maryland
Eric Goldberg Recruiting
Baltimore, Maryland, United States
Contact: Eric Goldberg, MD       egoldber@medicine.umaryland.edu   
Principal Investigator: Eric Goldberg, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States
Contact: Patrick Yachimski, MD    615-322-0128    patrick.yachimski@vanderbilt.edu   
Principal Investigator: Patrick Yachimski, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
University of Virginia
Investigators
Principal Investigator: Shyam Varadarajulu, MD University of Alabama at Birmingham
Principal Investigator: shyam varadarajulu, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01191814     History of Changes
Other Study ID Numbers: F100513025
Study First Received: August 12, 2010
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
pancreatic cancer
obstructive jaundice
Obstructive jaundice secondary to pancreatic cancer

Additional relevant MeSH terms:
Hyperbilirubinemia
Jaundice
Jaundice, Obstructive
Pancreatic Neoplasms
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014