Endobronchial Ultrasound Image Features in the Diagnosis of Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- The diagnostic value of EBUS image features
研究概览
简要总结
The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).
详细描述
The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The investigator evaluates the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of EBUS image features in diagnosing PPLs. EBUS is performed using an endoscope ultrasound system, which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are older than 18 year-old.
- •Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion is surrounded by lung parenchyma and invisible in standard bronchoscopy.
- •Patients who agree to undergo bronchoscopy without any contraindications.
- •Patients who have good compliance and sign informed consent.
排除标准
- •Absence of bronchus leading to or adjacent to the lesion from CT scan.
- •Refusal of participation.
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
- •Presence of concomitant endobronchial lesion during the bronchoscopy procedure
研究组 & 干预措施
EBUS group
EBUS and guide sheath (GS) are inserted into bronchi in the assistance of navigation bronchoscopy. The EBUS probe and GS are confirmed to reach the lesion by EBUS images, cytologic and pathologic specimens are obtained with or without fluoroscopic guidance.
干预措施: EBUS (Device)
结局指标
主要结局
The diagnostic value of EBUS image features
时间窗: one year
The diagnostic value includes sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate.
次要结局
- EBUS image features of adenocarcinoma(one year)
研究者
Xu Lei
Chief Physician
Shanghai Chest Hospital