Back to resultsComparison of Metal and Plastic Stents for Preoperative Biliary Decompression
Primary Purpose
Obstructive Jaundice, Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metal stent
Plastic stent
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Jaundice focused on measuring pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer
Eligibility 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).
Sites / Locations
- AdventHealth
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metal stent
Plastic Stent
Arm Description
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent
Outcomes
Primary Outcome Measures
Complications related to stent dysfunction
Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)
Secondary Outcome Measures
Procedural complications
Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.
Full Information
NCT ID
NCT01191814
First Posted
August 12, 2010
Last Updated
July 11, 2023
Sponsor
AdventHealth
Collaborators
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT01191814
Brief Title
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
Official Title
A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
October 13, 2022 (Actual)
Study Completion Date
October 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
University of Virginia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice, Pancreatic Cancer
Keywords
pancreatic cancer, obstructive jaundice, Obstructive jaundice secondary to pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metal stent
Arm Type
Active Comparator
Arm Description
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Arm Title
Plastic Stent
Arm Type
Active Comparator
Arm Description
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent
Intervention Type
Procedure
Intervention Name(s)
Metal stent
Intervention Description
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
Intervention Type
Procedure
Intervention Name(s)
Plastic stent
Intervention Description
Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.
Primary Outcome Measure Information:
Title
Complications related to stent dysfunction
Description
Complications related to stent dysfunction which include hyperbilirubinemia or cholangitis that warrant stent exchange (repeat intervention by ERCP)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural complications
Description
Complications related to the procedure which includes pancreatitis, perforation or hemorrhage.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Hasan, MD
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
AdventHealth
City
Orlando
State/Province
Florida
ZIP/Postal Code
32814
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
A manuscript will be developed following the closure of the study.
Learn more about this trial
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
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