Confocal Laser Endomicroscopy in the Diagnosis of Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
研究概览
简要总结
The purpose of the study is to describe confocal laser endomicroscopy (CLE) interpretation criteria for different types of peripheral pulmonary lesions (PPLs), with histopathological correlation, and to perform the validation of these criteria.
详细描述
CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial lung biopsy, CLE has the potential to provide real-time non-invasive diagnosis of PPLs ("optical biopsy"). In this study, we will obtain CLE images within the target lesion before taking a biopsy during transbronchial lung biopsy of PPLs. We will compare the results of the "optical biopsy" with the corresponding histopathological results and develop CLE interpretation criteria for different types of PPLs. In addition, we will perform the validation of these criteria to evaluate the ability of CLE to discriminate between benign and malignant PPLs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 older than 18 years.
- •Chest CT shows peripheral pulmonary lesions (peripheral pulmonary lesions are lesions beyond the segmental bronchi that are invisible during bronchoscopy), and transbronchial biopsy is considered necessary and feasible.
- •Patients who have good compliance and sign informed consent.
排除标准
- •Patients with known allergy for fluorescein.
- •Pregnant or lactating women.
- •Patients with contraindications of bronchoscopy.
- •The investigators believe that patient has other conditions that are not suitable for the study.
结局指标
主要结局
Diagnostic accuracy of CLE in differential diagnosis of benign and malignant PPLs
时间窗: 6 months post-procedure
Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign using our proposed CLE interpretation criteria divided by the total number of lesions.
次要结局
- Incidence of complications(1 month post-procedure)
- Sensitivity, specificity of CLE in differential diagnosis of benign and malignant PPLs(6 months post-procedure)
- positive predictive value, and negative predictive value of CLE in differential diagnosis of benign and malignant PPLs(6 months post-procedure)
- Diagnostic accuracy of CLE in differential diagnosis of different types of PPLs(6 months post-procedure)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital