Abstract
BACKGROUND AND OBJECTIVES: The diagnosis of malignant pancreatic cystic lesions (PCLs) remains challenging. Needle-based confocal laser endomicroscopy (nCLE) is an emerging promising imaging technique capable of real-time in vivo microscopic imaging of the cyst wall. We aimed to develop and validate a new nCLE diagnostic criteria for malignant mucinous cystic lesions (MLs). METHODS: Patients referred for EUS-FNA of indeterminate PCLs with at least one worrisome features according to Fukouka consensus were consecutively prospectively enrolled from July 2016 to July 2018. The final diagnosis was based on surgical histology, cytopathology, or committee consensus. Five investigators nonblindly reviewed nCLE features and identified potential diagnostic feature for malignant MLs, which was also reviewed in histology imaging accordingly. Furthermore, the nCLE diagnostic feature was evaluated with an independent nCLE dataset by two investigators in a double-blind manner. RESULTS: A nCLE pattern of dark aggregates of neoplastic cells was identified as diagnostic for MLs, which was consistent with histological findings of irregular branching and budding in malignant MLs. An independent validation revealed that the accuracy, sensitivity, and specificity of this feature for the diagnosis of malignant MLs were 94%, 75%, and 100%, respectively. CONCLUSION: The new nCLE criterion is promising for diagnosis of malignant MLs which warrants further confirmation in large cohort.