Overview

This trial is active, not recruiting.

Condition thoracic lesions
Treatment endobronchial ultrasound elastography
Sponsor Chinese PLA General Hospital
Start date October 2015
End date March 2016
Trial size 100 participants
Trial identifier NCT02755506, S2016-020-01

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients with thoracic lesions is going to undergo endobronchial ultrasound elastography followed by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).
endobronchial ultrasound elastography
Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography

Primary Outcomes

Measure
Elastography strain ratio
time frame: six months
Elasticity score
time frame: six months
Elastography area ratio
time frame: six months

Secondary Outcomes

Measure
Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.
time frame: six months

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
Principal investigator Liang-an Chen, MD,PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.