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



Status:Recruiting
Healthy:No
Age Range:18 - 95
Updated:9/9/2018
Start Date:May 25, 2017
End Date:May 2021
Contact:Maria Gloth, CCRC
Email:mgloth@ochsner.org
Phone:504-842-2417

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

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.

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).

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
We found this trial at
1
site
1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Janak N Shah, MD
Phone: 504-842-2417
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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mi
from
New Orleans, LA
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