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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
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 25, 2017
Last Updated
October 3, 2022
Sponsor
Ochsner Health System
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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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