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EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03392506
Recruitment Status : Unknown
Verified January 2018 by Jiayuan Sun, Shanghai Chest Hospital.
Recruitment status was:  Recruiting
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jiayuan Sun, Shanghai Chest Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Device: EBUS-TBNA-RTE Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Control Study of Intrathoracic Lymph Node in NSCLC Staging by EBUS-TBNA-RTE and Radiography
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The effectiveness of EBUS-TBNA-RTE [ Time Frame: 1year ]
    By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Unable to cooperate with the experiment

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392506


Contacts
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Contact: Xiaoxuan Zheng, MD 86-18918169140 milozheng59@163.com

Locations
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China, Shanghai
Shanghai Chest Hospital Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jiayuan Sun, MD, PhD    86-18017321598    jysun1976@163.com   
Sponsors and Collaborators
Jiayuan Sun
More Information
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Responsible Party: Jiayuan Sun, Director,Endoscopy Department,Shanghai Chest Hospital, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03392506    
Other Study ID Numbers: SHCHE201702
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiayuan Sun, Shanghai Chest Hospital:
CP-EBUS
EBUS-TBNA
Real time elasticity
Staging of lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases