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.