Study on The Value of Endobronchial Ultrasound Elastography in The Diagnosis of Thoracic Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Elastography strain ratio
研究概览
简要总结
The study aims to evaluate the role of endobronchial ultrasound elastography in differentiated diagnosis of benign and malignant thoracic lesions
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Elastography strain ratio
时间窗: six months
Elastography strain ratios were calculated between selected area of the lesions and the surrounding normal tissues.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of strain ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Elasticity score
时间窗: six months
Elasticity scores were obtained by analyzing elastography images.Scores:1-2: benign;3-4: malignant lesions. The sensitivity and specificity of elastography for the diagnosis of malignant thoracic lesions were calculated on the basis of above-specified criteria. The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
Elastography area ratio
时间窗: six months
Elastography area ratios were defined as following:areas as blue pixels/lesion areas as region of interest pixels.Then ROC curve was drawn to obtain the best diagnostic threshold value.According to the best cutoff value, the diagnostic accuracy,sensitivity and specificity of area ratio were calculated.The pathological results of EBUS-TBNA combined with results of long-term follow-up were defined as the gold standard.
次要结局
- Comparison of value of endobronchial ultrasound elastography in differentiated diagnosis of thoracic lesions with that of conventional ultrasound.(six months)
研究者
Chen Liang_An
Director of respiratory medicine
Chinese PLA General Hospital