Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Thoracic Lesions

Treatments: Device: endobronchial ultrasound elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT02755506

S2016-020-01

Details and patient eligibility

About

The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions

Full description

Ultrasound elastography has been gradually used in clinic with the rapid development of ultrasonic technique,and presents a promising application prospect in differentiated diagnosis of benign and malignant disease.The aim of the study is to evaluate the accuracy of endobronchial ultrasound elastography in the diagnosis of thoracic lesions.

Conventional ultrasound and ultrasound elastography are respectively used to examine thoracic lesions before aspiration,then the images are saved as video clips. Features of conventional ultrasound and parameters of ultrasound elastography are analysed and recorded by skilled worker. The investigators define the pathological results of EBUS-TBNA combined with results of six months follow-up as the "Gold Standard". The receiver operator characteristic curves are drawn to obtain area under the Curve (AUC) and the best diagnostic threshold values of each parameters. According to the best cutoff values, the investigators respectively calculate the accuracy, sensitivity, specificity, odds product of each parameters, and then compare them with each other to evaluate the value of ultrasound elastography

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hilar/mediastinal lymph lesions with a short axis more than 1 cm on thoracic computed tomography( CT) scan and/or positron emission tomography-computed tomography (PET-CT)
• With normal Coagulation function
• With normal cardio pulmonary function and be able to tolerate bronchoscopy
• No syphilis,acquired immune deficiency syndrome(AIDS) and other infectious diseases
• Willing and able to give written informed consent

Exclusion criteria

• Unable to lie in bed
• Allergy to narcotics such as lidocaine.
• Suffering from cardiovascular and cerebrovascular disease, severe lung liver and kidney dysfunction, or after drug treatment cannot maintain the normal.
• With abnormal Coagulation function or take anticoagulant drugs within the previous week.
• Hematological abnormalities, fever or highly suspected active tuberculosis patients.
• Women in the menstrual period.
• Excessive anxiety and can not tolerate bronchoscopy.
• Other conditions that are not suitable for inclusion in the study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

patients with thoracic lesions

Experimental group

Description:

Patients with thoracic lesions is going to undergo endobronchial ultrasound elastography followed by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).

Treatment:

Device: endobronchial ultrasound elastography