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 |
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.
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).
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
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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