Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
This prospective, multicenter diagnostic accuracy study will evaluate the clinical utility of needle-based confocal laser endomicroscopy (nCLE) for differentiating malignant from benign peripheral pulmonary lesions (PPLs). A total of 100 participants undergoing bronchoscopic evaluation of PPLs will be enrolled at three hospitals in China.
Following successful lesion localization using radial endobronchial ultrasound, nCLE imaging will be performed after intravenous administration of fluorescein, followed by standard bronchoscopic tissue sampling. nCLE findings will be compared with the final diagnosis established by histopathology, surgical pathology, or six-month clinical and imaging follow-up when necessary.
The primary outcomes are the sensitivity, specificity, positive predictive value, negative predictive value, and overall diagnostic accuracy of nCLE. Procedure duration and procedure-related adverse events will also be recorded. The investigators hypothesize that nCLE can accurately distinguish malignant from benign PPLs in real time.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Zhongbo Chen
- 电话号码：86+13777125910
- 邮箱：leonczb@163.com
学习地点
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Hefei
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Hefei、Hefei、中国、230022
- Anhui Chest Hospital
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接触：
- Fei Tang
- 电话号码：+86-13505696936
- 邮箱：tangfei1205@163.com
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Ningbo
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Zhejiang、Ningbo、中国、315000
- The First Affiliated Hospital of Ningbo University
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接触：
- ZHongbo Chen
- 电话号码：+86-13777125910
- 邮箱：leonczb@163.com
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
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接触：
- Jiayuan Sun
- 电话号码：+86-18017321598
- 邮箱：jysun1976@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
The study population will consist of adults aged 18 years or older with peripheral pulmonary lesions detected on chest computed tomography who are referred to the respiratory endoscopy units of three participating tertiary hospitals in China for clinically indicated diagnostic bronchoscopy and tissue sampling. Eligible patients will be prospectively screened and invited to participate. Participants must be willing to undergo radial probe endobronchial ultrasound localization and needle-based confocal laser endomicroscopy and must provide written informed consent. Patients with lesions ultimately diagnosed as either malignant or benign will be included.
描述
Inclusion Criteria:
- Age 18 years or older.
- A peripheral pulmonary lesion identified on chest CT.
- Bronchoscopic biopsy considered clinically necessary by the treating physician to establish a pathologic diagnosis.
- Willingness to undergo r-EBUS and nCLE examinations.
- Voluntary participation with written informed consent.
Exclusion Criteria:
- A contraindication to bronchoscopy, including severe cardiopulmonary disease,coagulation disorder, failure to discontinue anticoagulant therapy or anticoagulant medication for at least 5 days before the procedure, poor tolerance of anesthesia,psychiatric illness, or severe neurosis.
- Pregnancy or breastfeeding.
- Known allergy to fluorescein sodium.
- Coagulation disorder.
- A known allergic disorder, history of asthma, hepatic failure, renal failure, or another contraindication to fluorescein sodium injection.
- Continued use of a systemic beta-blocker on the day of the procedure, or inability to discontinue the beta-blocker safely as assessed by the investigator and anesthesiologist.
- Inability to cooperate with the study for any reason, or any other condition that the investigator considers unsuitable for enrollment.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions
大体时间：Up to 6 months after the index bronchoscopy
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Up to 6 months after the index bronchoscopy
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Incidence and Severity of Procedure-Related Adverse Events
大体时间：Periprocedural
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Periprocedural
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Duration of the nCLE Procedure
大体时间：Periprocedural
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Periprocedural
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Frequency of Guide-Sheath Adjustments Guided by Needle-Based Confocal Laser Endomicroscopy
大体时间：Periprocedural
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Periprocedural
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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