EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

NCT ID: NCT03392506

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EBUS-TBNA-RTE

Patients do CT、 PETCT examination and EBUS-TBNA-RTE

Group Type EXPERIMENTAL

EBUS-TBNA-RTE

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. Unable to cooperate with the experiment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiayuan Sun

OTHER

Sponsor Role lead

Responsible Party

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Jiayuan Sun

Director,Endoscopy Department,Shanghai Chest Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoxuan Zheng, MD

Role: CONTACT

86-18918169140

Facility Contacts

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Jiayuan Sun, MD, PhD

Role: primary

86-18017321598

Other Identifiers

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SHCHE201702

Identifier Type: -

Identifier Source: org_study_id

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