EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392506
• Other study ID #: SHCHE201702
• Status: Recruiting
• Phase: N/A
• First received: November 29, 2017
• Last updated: January 1, 2018
• Start date: November 28, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Shanghai Chest Hospital
• Contact: Xiaoxuan Zheng, MD
• Phone: 86-18918169140
• Email: milozheng59[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Intrathoracic lymph node enlargement

2. EBUS-TBNA operation can be performed

Exclusion Criteria:

1. Unable to cooperate with the experiment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• EBUS-TBNA-RTE
Every patient will do CT? PETCT and EBUS-TBNA-RTE.These three kind of examination will have their own result.The three methods of inspection will be compared by diagnostic rate

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiayuan Sun

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effectiveness of EBUS-TBNA-RTE	By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE	1year