2011-04
2012-07
2012-07
32
NCT01494077
University of California, Irvine
University of California, Irvine
OBSERVATIONAL
Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for Carcinoembryonic Antigen (CEA) Measurement
The purpose of this research project is to determine if pancreatic cyst fluid can be diluted and provide an accurate Carcinoembryonic Antigen (CEA) level. The investigators hypothesis is that pancreatic cyst fluid obtained by EUS-FNA can be diluted effectively and accurately for the measurement of CEA levels.
Potential subjects will be identified based on the indication of a pancreatic cyst requiring EUS-FNA. The procedure will be performed as usual per standard protocol with EUS-FNA of the cyst. Once the fluid is aspirated, it will be measured and if the fluid volume is 2.25 mL or greater than the patient will be included in the study. A micropipette will be used to ensure exact volumes are measured. The first 1 mL of cystic fluid will be sent to the lab for regular CEA analysis, per standard protocol. The remaining fluid, which would usually be discarded, will then be used for the study. The micropipette will be used to mix 0.75 mL of cyst fluid with 0.25 mL of normal saline (designated sample #2). Next, 0.5 mL of cyst fluid will be mixed with 0.5 mL of normal saline for the next study sample (designated sample #3). These two study samples will be sent to the lab separately using de-identified information, and these values will not be part of the patient's medical record and will not affect clinical management or decision-making. The study samples will be given a unique identifier that will not have any patient identification. The unique identifier will allow the study researchers to link the values to the correct patient by using a password protected program that cannot be accessed by the public. This study will not require any additional patient participation, and will not impact the length of the procedure. The only additional time will be from the study researchers and the EUS technologists diluting the samples, which will not affect the procedure time itself. If a single patient has more than one cyst, each cyst can be included in the study separately. No additional photographs, videos or data other than the standard data for the procedure will be produced.
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 |
|---|---|---|
2011-12-02 | N/A | 2014-12-10 |
2011-12-14 | N/A | 2014-12-12 |
2011-12-16 | N/A | 2014-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : EUS-FNA of Pancreatic Cyst Patients who have a pancreatic cyst requiring standard of care EUS-FNA that yields 2.25 ML (or greater) of fluid will be included in the study. | OTHER: Laboratory processing for results
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Accuracy of diluted CEA level | The primary aim of this study is to determine if pancreatic cyst fluid can be diluted and provide an accurate CEA level. | Pancreatic fluid is aspirated once during the procedure. |
| 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
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