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临床试验/NCT03169842
NCT03169842已完成不适用

Accuracy of Cyst Fluid Glucose for the On-site Diagnosis of Mucinous Pancreatic Cysts

Ochsner Health System1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年5月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
1
主要终点
Cyst fluid glucose level

研究概览

简要总结

This study evaluates the utility of using cyst fluid glucose levels to diagnose mucinous pancreatic cysts during endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) procedures.

详细描述

Mucinous pancreatic cysts are considered pre-cancerous. The standard evaluation of pancreatic cysts usually includes endoscopic ultrasound-guided fine needle aspiration (EUS-FNA). The cyst fluid sample from EUS-FNA is routinely sent for lab analysis (carcinoembryonic antigen-CEA) and cytology assessment. The diagnosis of a mucinous cyst is usually based on those results.

For study participants undergoing EUS-FNA, a small portion of the cyst fluid will be analyzed for glucose levels using a bedside glucometer in addition to the routine analyses. A low cyst fluid glucose level may correlate with a diagnosis of a mucinous cyst. The primary aim of this study will be to determine if a low cyst fluid glucose level correlates with standard laboratory cyst fluid analysis (CEA) in establishing a diagnosis of a mucinous pancreatic cyst.

Secondary aims of this study will be: (1) comparing the accuracy of cyst fluid glucose to CEA level among subjects with a proven diagnosis of a mucinous cyst (based on surgery or cytopathology findings), and (2) determining the optimal cyst fluid glucose level that correlates to a proven diagnosis of a mucinous cyst (based on subjects who undergo surgery or have a diagnosis based on cytopathology).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All adults undergoing standard-of-care EUS-FNA procedures for the evaluation of pancreatic cysts are eligible to participate
  • •Minimum of 1mL of cyst fluid must be aspirated in order to be enrolled in the study

排除标准

  • •Inability to perform pancreatic cyst fluid sampling
  • •<1mL of cyst fluid is aspirated during EUS-FNA

研究组 & 干预措施

Cyst fluid glucose

Experimental

Single arm- cyst fluid glucose will be measured from pancreatic cyst fluid aspirate

干预措施: pancreatic cyst fluid glucose analysis using a bedside glucometer (Device)

结局指标

主要结局

Cyst fluid glucose level

时间窗: immediate, point-of-care measurement at time of EUS-FNA of pancreatic cyst fluid

concentration of cyst fluid glucose based on measurement with bedside glucometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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