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Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

This study is currently recruiting participants.
Verified August 2017 by Florida Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01675908
First Posted: August 30, 2012
Last Update Posted: August 3, 2017
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.
Collaborators:
Vanderbilt University
University of Maryland
Information provided by (Responsible Party):
Florida Hospital
  Purpose
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression

Condition Intervention
Obstructive Jaundice Pancreatic Cancer Procedure: Stent Dysfunction Procedure: Complications

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

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Complications related to stent dysfunction [ Time Frame: 30 days ]
    Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.


Secondary Outcome Measures:
  • Procedural complications [ Time Frame: 30 days ]
    This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.


Estimated Enrollment: 84
Study Start Date: July 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (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. The rates (%) of stent dysfunction and complications will be evaluated.
Procedure: Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Procedure: Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
Active Comparator: Plastic Stent
At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
Procedure: Stent Dysfunction
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Procedure: Complications
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  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): NCT01675908


Contacts
Contact: shyam varadarajulu, MD svaradarajulu@yahoo.com

Locations
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32814
Contact: shyam varadarajulu, MD    407-303-2570    svaradarajulu@yahoo.com   
Principal Investigator: shyam varadarajulu, MD         
Sponsors and Collaborators
Florida Hospital
Vanderbilt University
University of Maryland
Investigators
Principal Investigator: shyam varadarajulu, MD Florida Hospital Center for Interventional Endoscopy
  More Information

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT01675908     History of Changes
Other Study ID Numbers: 356090
First Submitted: August 28, 2012
First Posted: August 30, 2012
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A manuscript will be developed following completion of the study.

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