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

Ochsner Health System

Status: Completed

Conditions: Pancreatic Cyst

Treatments: Device: pancreatic cyst fluid glucose analysis using a bedside glucometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03169842

2016.227.C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 37 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Cyst fluid glucose

Experimental group

Description:

Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate

Treatment:

Device: pancreatic cyst fluid glucose analysis using a bedside glucometer