Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Florida Hospital
Sponsor:
Collaborators:
Vanderbilt University
University of Maryland
Information provided by (Responsible Party):
Florida Hospital
ClinicalTrials.gov Identifier:
NCT01675908
First received: August 28, 2012
Last updated: January 8, 2014
Last verified: January 2014
  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
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 Stents for Preoperative Biliary Decompression in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Complications related to stent dysfunction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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: July 2014
Estimated Primary Completion Date: July 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. 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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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: 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         
United States, Maryland
University of Maryland 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       patrick.yachimski@Vanderbilt.Edu   
Principal Investigator: Patrick Yachimski, 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

No publications provided

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT01675908     History of Changes
Other Study ID Numbers: 356090
Study First Received: August 28, 2012
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014