A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
研究概览
简要总结
Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old；
- •Enlargement of at least one intrathoracic LN (short diameter > 1 cm) or central parenchymal lung lesions adjacent to the airway detected on chest CT, or increased fluorodeoxyglucose uptake in at least one intrathoracic lymph node on PET / CT (standardized uptake value > 2.5)；
- •CP-EBUS-TBNA is required to determine the diagnosis or staging, the patient agreed to undergo CE-EBUS, and there were no contraindications to EBUS-TBNA;
- •Patients who have good compliance and sign informed consent.
排除标准
- •Patients with known hypersensitivity to ultrasound contrast components;
- •Patients with severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg);
- •Patients with angina pectoris, acute coronary syndrome, clinically unstable ischemic heart disease, heart failure, cardiac dysfunction, and cardiac disease with right-to-left shunting;
- •Patients with uncontrolled essential hypertension and adults with respiratory distress syndrome;
- •Pregnant or lactating women；
- •Patients with contraindications to bronchoscopy；
- •Patients with other conditions that, in the opinion of the investigator, make the patient unsuitable for the study.
研究组 & 干预措施
Contrast-Enhanced Endobronchial Ultrasound
干预措施: Contrast-enhanced endobronchial ultrasound (Device)
结局指标
主要结局
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy
时间窗: 6 month post-procedure
Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using CE-EBUS interpretation criteria.
Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions
时间窗: 6 month post-procedure
Diagnostic accuracy was defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using the CE-EBUS interpretation criteria.
次要结局
- Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy(6 months post-procedure)
- Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions(6 months post-procedure)
研究者
Jiayuan Sun
Vice-President of the hospital
Shanghai Chest Hospital