Probe-based confocal laser endomicroscopy (CLE) is an innovative technique for real-time, non-invasive analysis of the surface epithelium.
While being successfully used for diagnosis by experts, this method has not yet been established in clinical routine, partly due to the lack of standards and criteria for classifying various lesions. Our aim was to determine the diagnostic value and inter-rater reliability of CLE in detecting malignant lesions of the vocal cords. 58 video sequences were extracted from the probe-based CLE (GastroFlex probe with a Cellvizio® laser system) examinations of 3 patients with squamous cell carcinomas and 4 patients with benign alterations of the vocal folds. Two ENT surgeons, who were blinded to the histological result, were asked to identify the sequences representing a carcinoma. We showed an accuracy, sensitivity, specificity, PPV and NPV of 91.38-96.55%, 100%, 87.8-95.2%, 77.27-89.47% and 100%, respectively, with an inter-rater reliability of k = 0.89 (“almost perfect agreement”). Probe-based CLE is a promising method for diagnosis and assessment of vocal fold lesions in vivo. Our results suggest that, with adequate training, the diagnostic value of this technique can be improved and potentially provide important information during oncological surgery.