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临床试验/NCT01494077
NCT01494077已完成不适用

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

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Accuracy of diluted CEA level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Cysts yielding less than 2.25ml of fluid

结局指标

主要结局

Accuracy of diluted CEA level

时间窗: Pancreatic fluid is aspirated once during the procedure.

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth J. Chang

Professor of Clinical Medicine

University of California, Irvine

研究点 (1)

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