Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for Carcinoembryonic Antigen (CEA) Measurement

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kenneth J. Chang, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01494077
First received: December 2, 2011
Last updated: December 15, 2011
Last verified: December 2011

December 2, 2011
December 15, 2011
April 2011
June 2012   (final data collection date for primary outcome measure)
Accuracy of diluted CEA level [ Time Frame: Pancreatic fluid is aspirated once during the procedure. ] [ Designated as safety issue: No ]
The primary aim of this study is to determine if pancreatic cyst fluid can be diluted and provide an accurate CEA level.
Accuracy of diluted CEA level [ Time Frame: Pancreatic fluid will be collected at the time of procedure. [note to QA: I don't know how else to reword this. The fluid is aspirated once during the procedure. That fluid is sent to the lab for testing. Please advise.] ] [ Designated as safety issue: No ]
The primary aim of this study is to determine if pancreatic cyst fluid can be diluted and provide an accurate CEA level.
Complete list of historical versions of study NCT01494077 on ClinicalTrials.gov Archive Site
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Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for Carcinoembryonic Antigen (CEA) Measurement
Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for 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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients who are already scheduled for EUS-FNA of a pancreatic cyst at the H.H. Chao Comprehensive Digestive Disease Center at UC Irvine Medical Center. The procedure will be performed as usual per standard of care 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.

Pancreatic Cyst
Other: Laboratory processing for results
There is no intervention. Extra fluid that is normally discarded will be processed.
Other Name: Laboratory processing for results
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.
Intervention: Other: Laboratory processing for results
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
June 2013
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for EUS-FNA of a pancreatic cyst
  • Cyst must yield 2.25ml (or greater) of fluid

Exclusion Criteria:

  • Cysts yielding less than 2.25ml of fluid
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01494077
HS#2011-8161
No
Kenneth J. Chang, University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Kenneth J. Chang, MD University of California, Irvine
University of California, Irvine
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP