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NCT03169842 Clinical Trial

Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts

Pancreatic Cyst Clinical Trial

Official title:
Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03169842
Other study ID # 2016.227.C
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2017
Est. completion date April 18, 2022

Study information
Verified date October 2022
Source Ochsner Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date April 18, 2022
Est. primary completion date April 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• pancreatic cyst fluid glucose analysis using a bedside glucometer
Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.

Locations
Country Name City State
United States Ochsner Medical Center New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cyst fluid glucose level concentration of cyst fluid glucose based on measurement with bedside glucometer immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid
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