Digital confocal microscopy for real-time diagnosis of pancreatic solid lesion: a multicentre study

Aims The feasibility of Fluorescence Confocal laser microscopy (FCM) with MAVIG VivaScope in EUS-FNB samples of pancreatic solid lesion has been assessed, showing good concordance with final histological evaluation. We aim at evaluate the accuracy of FCM in predicting the diagnosis of pancreatic solid lesions EUS-TA samples and its agreement with final histological diagnosis. The secondary aims was to assess the association between type, size of needles and EUS technique and the diagnostic sample obtainment.

Methods Multicentre prospective study involving three high level European Hospitals. Obtained samples evaluated at FCM and classified as “Inadequate” or “Adequate” (Benign; Suspicious; Malignant).Type, size of needle used and the technique used recorded.

Results From April to August 2023, 80 patients enrolled.In 78.5% FNB needle was used.In 66.3% procedures 22G needle was used.Considering the final histological evaluation on the same sample as the gold standard, the diagnosis at Vivascope evaluation was confirmed in 94.8% patients.The use of FNB needle was not associated with higher rate of diagnostic samples at Vivascope evaluation (88.8% vs 100% p 0.33) and neither the needle size (19 G 100% vs 22 G 88.7% vs 25 G 96.2 p 0.52) or sampling technique (93.9% vs 78.5% p 0.09).The VivaScope’s Sensitivity was 97.33% (95% CI 90.7-99.7%)Specificity 80.0% (95% CI 28.4-99.5%) and the Accuracy was 96.3% (95% CI 89-99.2%).There was moderate concordance between the Vivascope diagnosis and the final histological diagnosis (kappa Cohen’s coefficient 0.58).

Conclusions FCM provide fast information about sample adequacy and diagnosis of EUS TA with high accuracy. FCM could eliminate the differences between needle type and size linked with diagnostic sample obtainment.

Publication History

Article published online:
27 March 2025