Confocal Laser Endomicroscopy Combined With Rapid On-Site Cytological Evaluation for the Diagnosis of Intrathoracic Lymphadenopathy
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 combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy
研究概览
简要总结
The purpose of this study is to describe and validate confocal laser endomicroscopy(CLE) and rapid on-site evaluation(ROSE) interpretation criteria for different types of intrathoracic lymphadenopathy.
详细描述
This is a single-arm, single-center and prospective study. Approximately 150 patients with intrathoracic lymphadenopathy will be included to receive CLE and ROSE for the diagnosis of the lesions. CLE is a modern imaging technique that uses an excitation laser light to create real-time microscopic images of tissues. During transbronchial biopsy, CLE has the potential to provide rea-lime non-invasive diagnosis of intrathoracic lymphadenopathy ('optical biopsy'). Rapid on-site evaluation (ROSE) is an important auxiliary technology for transbronchial biopsy, providing rapid cytopathological evaluation of specimens during operation and feedback on specimen quality and preliminary diagnosis of lesions. In this study, we will obtain CLE images and ROSE images of the target lesion . We will compare the results of the 'optical biopsy' and cytological evaluation with the corresponding histopathological results and develop CLE and ROSE interpretation criteria for different types of intrathoracic lymphadenopathy. In addition, we will perform the validation of these criteria to evaluate the ability of CLE and ROSE to discriminate between benign and malignant intrathoracic lymphadenopathy.
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
- •Age >18 years old.
- •Chest CT shows at least one enlarged intrathoracic lymph node (short axis >1 cm), or PET / CT shows increased fluorodeoxyglucose uptake (standard uptake value > 2.5) in at least one intrathoracic lymph node.
- •CP-EBUS-TBNA is required to determine the diagnosis or staging.
- •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 combined with ROSE in 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 using our proposed CLE and ROSE interpretation criteria divided by the total number of lesions.
次要结局
- Diagnosis accuracy of CLE combined with ROSE in differential diagnosis of different types of intrathoracic lymphadenopathy(6 months post-procedure)
- Diagnosis accuracy of CLE or ROSE alone in differential diagnosis of different types of intrathoracic lymphadenopathy(6 months post-procedure)
- Sensitivity, specificity, positive predictive value and negative predictive value of CLE combined with ROSE in differential diagnosis of benign and malignant intrathoracic lymphadenopathy(6 months post-procedure)
- Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of CLE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy(6 months post-procedure)
- Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of ROSE alone in differential diagnosis of benign and malignant intrathoracic lymphadenopathy(6 months post-procedure)
- Incidence of complications(1 month post-procedure)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital