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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyst fluid glucose | Experimental | Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreatic cyst fluid glucose analysis using a bedside glucometer | Device | Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
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| ID | Term |
|---|---|
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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