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

NCT01494077 | Completed

• 1 other identifier: HS#2011-8161
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cyst

Keywords

Pancreatic Cyst Fluid; Dilution; Carcinoembryonic Antigen (CEA)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

Laboratory processing for results OTHER

There is no intervention. Extra fluid that is normally discarded will be processed.

EUS-FNA of Pancreatic Cyst

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Cysts yielding less than 2.25ml of fluid

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

H. H. Chao Comprehensive Digestive Disease Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Kenneth J. Chang, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 16, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

US (1)