Back to resultsEBUS-TBNA-RTE VS Radiography in Staging of NSCLC
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EBUS-TBNA-RTE
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Cancer focused on measuring CP-EBUS, EBUS-TBNA, Real time elasticity, Staging of lung cancer
Eligibility Criteria
Inclusion Criteria:
- Intrathoracic lymph node enlargement
- EBUS-TBNA operation can be performed
Exclusion Criteria:
1. Unable to cooperate with the experiment
Sites / Locations
- Shanghai Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBUS-TBNA-RTE
Arm Description
Patients do CT、 PETCT examination and EBUS-TBNA-RTE
Outcomes
Primary Outcome Measures
The effectiveness of EBUS-TBNA-RTE
By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03392506
Brief Title
EBUS-TBNA-RTE VS Radiography in Staging of NSCLC
Official Title
A Control Study of Intrathoracic Lymph Node in NSCLC Staging by EBUS-TBNA-RTE and Radiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jiayuan Sun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
CP-EBUS, EBUS-TBNA, Real time elasticity, Staging of lung cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EBUS-TBNA-RTE
Arm Type
Experimental
Arm Description
Patients do CT、 PETCT examination and EBUS-TBNA-RTE
Intervention Type
Device
Intervention Name(s)
EBUS-TBNA-RTE
Intervention Description
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
Primary Outcome Measure Information:
Title
The effectiveness of EBUS-TBNA-RTE
Description
By comparison of the diagnostic accuracy of CT ,PET-CT and EBUS-TBNA-RTE
Time Frame
1year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intrathoracic lymph node enlargement
EBUS-TBNA operation can be performed
Exclusion Criteria:
1. Unable to cooperate with the experiment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxuan Zheng, MD
Phone
86-18918169140
Email
milozheng59@163.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayuan Sun, MD, PhD
Phone
86-18017321598
Email
jysun1976@163.com
12. IPD Sharing Statement
Learn more about this trial
EBUS-TBNA-RTE VS Radiography in Staging of NSCLC
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