跳至主要内容
临床试验/NCT03392506
NCT03392506Unknown不适用

A Control Study of Intrathoracic Lymph Node in NSCLC Staging by EBUS-TBNA-RTE and Radiography

Jiayuan Sun1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
The effectiveness of EBUS-TBNA-RTE

研究概览

简要总结

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

详细描述

The newly developed convex array can be used to identify the hardness of the lymph nodes and estimate the benign and malignant lymph nodes indirectly through the quantitative and visualized analysis of the elastic coefficient of the bronchus through the CP-EBUS elastography mode.

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

120cases will be enrolled.Compared with the commonly used methods to evaluate intrathoracic lymph node metastasis, the accuracy of chest CT and PET-CT were compared. The lymph node staging method and the final pathological gold standard of the three groups were compared, so as to verify the accuracy and clinical popularization of the bronchial ultrasound elastography mode.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intrathoracic lymph node enlargement
  • EBUS-TBNA operation can be performed

排除标准

  • Unable to cooperate with the experiment

研究组 & 干预措施

EBUS-TBNA-RTE

Experimental

Patients do CT、 PETCT examination and EBUS-TBNA-RTE

干预措施: EBUS-TBNA-RTE (Device)

结局指标

主要结局

The effectiveness of EBUS-TBNA-RTE

时间窗: 1year

By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE

次要结局

未报告次要终点

研究者

发起方
Jiayuan Sun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jiayuan Sun

Director,Endoscopy Department,Shanghai Chest Hospital

Shanghai Chest Hospital

研究点 (1)

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