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2017-05-25
2022-04-18
2022-04-18
37
NCT03169842
Ochsner Health System
Ochsner Health System
INTERVENTIONAL
Cyst Fluid Glucose for 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).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-05-25 | N/A | 2022-10-03 |
2017-05-25 | N/A | 2022-10-05 |
2017-05-30 | N/A | 2022-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
