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
  Purpose

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.


Condition Intervention
Pancreatic Cyst
Other: Laboratory processing for results

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Accuracy of Dilution of EUS-FNA Pancreatic Cyst Fluid for CEA Measurement

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
There is no intervention. Extra fluid that is normally discarded will be processed.
Other Name: Laboratory processing for results

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494077

Locations
United States, California
H. H. Chao Comprehensive Digestive Disease Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Kenneth J. Chang, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Kenneth J. Chang, Professor of Clinical Medicine, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01494077     History of Changes
Other Study ID Numbers: HS#2011-8161
Study First Received: December 2, 2011
Last Updated: December 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Pancreatic Cyst Fluid
Dilution
Carcinoembryonic Antigen (CEA)

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014