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Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

This study is currently recruiting participants.
Verified April 2015 by Shyam Varadarajulu, Florida Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191814
First Posted: August 31, 2010
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Shyam Varadarajulu, Florida Hospital
  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 Procedure: Plastic stent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Trial COmparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Shyam Varadarajulu, Florida Hospital:

Primary Outcome Measures:
  • Complications related to stent dysfunction [ Time Frame: 30 days ]
    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 ]
    Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.


Estimated Enrollment: 84
Study Start Date: July 2010
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metal stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Procedure: Metal stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Active Comparator: Plastic Stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent
Procedure: Plastic stent
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.

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 as there will be better drainage of the obstructed biliary system with fewer adverse events.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Florida Hospital
University of Virginia
Investigators
Principal Investigator: Shyam Varadarajulu, MD University of Alabama at Birmingham
  More Information

Responsible Party: Shyam Varadarajulu, Principal Investigator, Florida Hospital
ClinicalTrials.gov Identifier: NCT01191814     History of Changes
Other Study ID Numbers: F100513025
First Submitted: August 12, 2010
First Posted: August 31, 2010
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by Shyam Varadarajulu, Florida Hospital:
pancreatic cancer
obstructive jaundice
Obstructive jaundice secondary to pancreatic cancer

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


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