Background and study aims:  Endoscopic ultrasound fine-needle aspiration (EUS-FNA) is a keystone in diagnosing and staging of pancreatic masses. Recently, a microfiber that can pass through a 19-gauge needle has been introduced for confocal laser endomicroscopy (nCLE). The aims of this study were to evaluate the diagnostic value and the reproducibility of nCLE criteria for solid malignant lesions.

Patients and methods:  This prospective dual-center study included patients with pancreatic masses suspicious of malignancy referred for EUS-FNA. Endomicroscopic imaging was performed under EUS-guidance until organ-specific structures were obtained. Afterwards, standard cytology was obtained and patients were followed for up to 12 months. All nCLE parameters included in former studies were correlated with the final diagnosis (dark lobular structures/normal acinar cells, dark cell aggregates > 40 µm, dilated irregular vessels with fluorescein leakage, fine white fibrous bands, small black cell movements, pseudoglandular structures). Finally, three CLE novices and three CLE experts assessed the unedited movies from all patients.

Results:  Twenty-eight patients were enrolled in the study. A final diagnosis was obtained in 24 patients (86 %). One patient (3 %) died before a diagnosis was obtained, while 3 were lost to follow-up (11 %). In 18/24 patients (74 %) the diagnosis was malignant. The mean sensitivity, specificity, and accuracy for the nCLE parameters ranged from 19 - 93 %, 0 - 56 %, 26 - 69 %, respectively. The inter-observer values ranged from κ = 0.20 - 0.41 for novices and κ = -0.02 - 0.38 for experts.

Conclusions:  The diagnostic value of nCLE in solid pancreatic masses is questionable and the inter-observer agreement for both novices and CLE experts appears limited.