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Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

Primary Purpose

Obstructive Jaundice, Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stent Dysfunction
Complications
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Jaundice

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metal stent

Plastic Stent

Arm Description

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.

At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.

Outcomes

Primary Outcome Measures

Complications related to stent dysfunction
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
This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.

Full Information

First Posted
August 28, 2012
Last Updated
February 15, 2022
Sponsor
AdventHealth
Collaborators
Vanderbilt University, University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT01675908
Brief Title
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
Official Title
Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 22, 2012 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
Vanderbilt University, University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metal stent
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Plastic Stent
Arm Type
Active Comparator
Arm Description
At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
Intervention Type
Procedure
Intervention Name(s)
Stent Dysfunction
Intervention Description
Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
Intervention Type
Procedure
Intervention Name(s)
Complications
Intervention Description
Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
Primary Outcome Measure Information:
Title
Complications related to stent dysfunction
Description
Evaluate the rates of complications (%) related to stent dysfunction which include persistent hyperbilirubinemia and cholangitis that warrant stent exchange by a repeat ERCP.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural complications
Description
This will be measured as proportion of patients who encounter a procedural complication (%) during ERCP that includes pancreatitis, perforation or hemorrhage.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 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
shyam varadarajulu, MD
Organizational Affiliation
Florida Hospital Center for Interventional Endoscopy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
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 completion of the study.

Learn more about this trial

Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression

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