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.
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.
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.
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.
Cohort
Prospective
Confocal Laser Endomicroscopy
DeviceAfter successful localization of the peripheral pulmonary lesion using radial probe endobronchial ultrasound, a needle-based confocal laser endomicroscopy probe will be advanced through the same guide sheath. Following intravenous administration of 200 mg fluorescein sodium diluted in 8 mL of normal saline, the probe will be placed in gentle contact with the target lesion to acquire real-time microscopic images. A 1.4-mm probe will be used whenever feasible; a 0.8-mm probe may be used when the larger probe cannot pass through the working channel or guide sheath. The probe position may be adjusted to obtain diagnostically meaningful images. Images will be recorded before bronchoscopic tissue sampling and subsequently evaluated using predefined criteria for malignant and benign lesions. The nCLE findings will be compared with the final diagnosis established by histopathology and follow-up when necessary.
Diagnostic Accuracy of Needle-Based Confocal Laser Endomicroscopy for Differentiating Malignant From Benign Peripheral Pulmonary Lesions
Incidence and Severity of Procedure-Related Adverse Events
Duration of the nCLE Procedure
Frequency of Guide-Sheath Adjustments Guided by Needle-Based Confocal Laser Endomicroscopy
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First Affiliated Hospital of Ningbo University
Lead sponsor
Shanghai Chest Hospital
Collaborator
Anhui Chest Hospital
Collaborator
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