Cyst Fluid Glucose for On-site Diagnosis of Mucinous Pancreatic Cysts
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|ClinicalTrials.gov Identifier: NCT03169842|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cyst||Device: pancreatic cyst fluid glucose analysis using a bedside glucometer||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts|
|Actual Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2021|
Experimental: Cyst fluid glucose
Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate
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.
- Cyst fluid glucose level [ Time Frame: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid ]concentration of cyst fluid glucose based on measurement with bedside glucometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169842
|Contact: Maria Gloth, CCRCemail@example.com|