Clinical trial NCT02755506: Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
Official title: Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Lesions
Keywords: Ultrasound elastography
Thoracic lesions
EBUS-TBNA
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Elastography strain ratio
timeFrame: six months
measure: Elasticity score
timeFrame: six months
measure: Elastography area ratio
timeFrame: six months
Secondary outcomes:
measure: Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.
timeFrame: six months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Liang-an Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: