Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
Primary Purpose
Pancreatic Cyst
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pancreatic cyst fluid glucose analysis using a bedside glucometer
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cyst
Eligibility Criteria
Inclusion Criteria:
- All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
- Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study
Exclusion Criteria:
- Inability to perform pancreatic cyst fluid sampling
- <1mL of cyst fluid is aspirated during EUS-FNA
Sites / Locations
- Ochsner Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cyst fluid glucose
Arm Description
Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate
Outcomes
Primary Outcome Measures
Cyst fluid glucose level
concentration of cyst fluid glucose based on measurement with bedside glucometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03169842
Brief Title
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
Official Title
Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.
Detailed Description
Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.
For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.
Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cyst fluid glucose
Arm Type
Experimental
Arm Description
Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate
Intervention Type
Device
Intervention Name(s)
pancreatic cyst fluid glucose analysis using a bedside glucometer
Intervention Description
Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.
Primary Outcome Measure Information:
Title
Cyst fluid glucose level
Description
concentration of cyst fluid glucose based on measurement with bedside glucometer
Time Frame
immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study
Exclusion Criteria:
Inability to perform pancreatic cyst fluid sampling
<1mL of cyst fluid is aspirated during EUS-FNA
Facility Information:
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
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