Vivascope for real-time diagnosis of pancreatic solid lesion: A multicentre study

Background: Fluorescence Confocal laser microscopy (FCM) with Vivascope in EUS-fine needle biopsy (FNB) samples of pancreatic solid lesion has shown good concordance with final histological evaluation.To assess the accuracy of Vivascope in predicting the diagnosis of EUS-guided pancreatic solid lesions samples.To assess the agreement between Vivascope and final histological diagnosis and the possible association between type and size of needles and the histological diagnosis obtainment. Methods: Multicentre prospective study involving 3 European referral Endoscopy Units. Consecutive patients undergoing EUS-guided sampling of pancreatic solid masses were enrolled. The same samples were assessed by Vivascope and conventional pathology and classified as “Inadequate” or “Adequate” (Benign; Suspicious; Malignant). Results: From April to August 2023 80 patients enrolled. In 78.5% FNB needle was used and in 66.3% it was a 22G needle.The FCM diagnosis with Vivascope was confirmed in 94.8% patients after conventional pathology.The use of FNB needle was not associated with higher rate of diagnostic samples at Vivascope evaluation (88.8% vs 100%, p=0.33), neither were the needle size (19 G 100% vs 22 G 88.7% vs 25 G 96.2 p=0.52) or the sampling technique (93.9% vs 78.5% p=0.09). Vivascope sensitivity was 97.33% (95% CI 90.7-99.7%), Specificity was 80.0% (95% CI 28.4-99.5%) and Accuracy 96.3% (95% CI 89-99.2%).There was moderate concordance between FCM diagnosis with Vivascope and the final histological diagnosis (kappa Cohen's coefficient 0.58). Conclusions: Our study supports the reliability of FCM with Vivascope for both sample adequacy and diagnosis.It may prevent possible diagnostic delays and allowing centralization of microscopic assessment thanks to its digital nature.