EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

January 1, 2018 updated by: Jiayuan Sun

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Unable to cooperate with the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EBUS-TBNA-RTE
Patients do CT、 PETCT examination and EBUS-TBNA-RTE
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effectiveness of EBUS-TBNA-RTE
Time Frame: 1year
By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiayuan Sun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

January 1, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHCHE201702

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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