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Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for CEA Measurement

18 Years
Open (Enrolling by invite only)
Pancreatic Cyst

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Trial Information

Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for CEA Measurement

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

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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Accuracy of diluted CEA level

Outcome Description:

The primary aim of this study is to determine if pancreatic cyst fluid can be diluted and provide an accurate CEA level.

Outcome Time Frame:

Pancreatic fluid is aspirated once during the procedure.

Safety Issue:


Principal Investigator

Kenneth J. Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Institutional Review Board

Study ID:




Start Date:

April 2011

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Cyst
  • Pancreatic Cyst Fluid
  • Dilution
  • Carcinoembryonic Antigen (CEA)
  • Cysts
  • Pancreatic Cyst



H. H. Chao Comprehensive Digestive Disease Center Orange, California  92868