EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

Not Applicable

• Conditions: Lung Cancer

• Registration Number: NCT03392506
• Lead Sponsor: Jiayuan Sun

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-11-28
• Study First Submitted: 2017-11-29
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-01
• Last Update Submitted: 2018-01-01
• Study First Posted: 2018-01-08
• Last Update Posted: 2018-01-08
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Intrathoracic lymph node enlargement
2. EBUS-TBNA operation can be performed

Exclusion Criteria

1. Unable to cooperate with the experiment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The effectiveness of EBUS-TBNA-RTE	1year	By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China