EBUS-TBNA-RTE VS Radiography in Staging of NSCLC | NCT03392506

Studies
EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

NCT03392506

Sponsor

Jiayuan Sun

Status

Unknown status

Last Update Posted

Jan 8, 2018Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Lung Cancer

Interventions

EBUS-TBNA-RTE

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 28, 2017Actual

Primary Completion Date

Dec 31, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

Nov 29, 2017

First Submission Date that Met QC Criteria

Jan 1, 2018

First Posted Date

Jan 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2018

Last Update Posted Date

Jan 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiayuan Sun, Director,Endoscopy Department,Shanghai Chest Hospital, Shanghai Chest HospitalSponsor-Investigator

Lead Sponsor

Jiayuan SunOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EBUS-TBNA-RTE	Experimental	Patients do CT、 PETCT examination and EBUS-TBNA-RTE	Device: EBUS-TBNA-RTE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EBUS-TBNA-RTE	Device	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Intrathoracic lymph node enlargement
EBUS-TBNA operation can be performed

Exclusion Criteria:

1. Unable to cooperate with the experiment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoxuan Zheng, MD	Contact	86-18918169140		milozheng59@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Chest Hospital	Recruiting	Shanghai	Shanghai Municipality	200030	China

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided