Needle-based confocal laser endomicroscopy for the diagnosis of pancreatic cystic lesions: an international external interobserver and intraobserver study (with videos). Krishna SG, Brugge WR, Dewitt JM, Kongkam P, Napoleon B, Robles-Medranda C, Tan D, El-Dika S, McCarthy S, Walker J, Dillhoff ME, Manilchuk A, Schmidt C, Swanson B, Shah ZK, Hart PA, Conwell D. Gastrointest Endosc. 2017 Mar 9. [Epub ahead of print]

BACKGROUND AND AIMS:EUS-guided nCLE characteristics of common types of PCLs have been identified; however surgical histopathology was available in a minority of subjects. We sought to assess the performance characteristics of EUS-nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of subjects with a definitive diagnosis.

METHODS:Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 subjects with surgical (n=23) or clinical (n=6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the κ statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean ± standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of κ values were used.RESULTS:A total of 29 (16 mucinous-PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous-PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean ± SD) were κ = 0.81 (almost perfect); 95% CI, 0.71-0.90; and κ = 0.86 ± 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of SCAs were 99%, 98%, and 98%, respectively. The IOA and IOR (mean±SD) for recognizing characteristic image pattern of SCA were κ=0.83 (almost perfect); 95% CI, 0.73-0.92; and κ=0.85±0.11 (almost perfect), respectively.CONCLUSION:EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy, and inter-and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multi-center studies to evaluate EUS-nCLE.

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