Mauna Kea Technologies announced the final results of a clinical trial assessing the use of probe-based confocal laser endomicroscopy in the diagnosis of biliary cancer during ERCP.
The results of the multi-center international prospective FOCUS trial were published in Gastrointestinal Endoscopy.
The trial evaluated the diagnostic performance of pCLE with Cellvizio, a multidisciplinary confocal laser endomicroscopy platform, for the characterization of biliary strictures and thus for the presence of biliary cancer.
Among the 112 patients enrolled in this study, pCLE correctly diagnosed 88% of patients when combined with ERCP. Also, tissue sampling — traditional biopsies — was inconclusive for a majority of patients while pCLE was inconclusive for only 16 patients, which helped physicians to correctly identify the condition of 54 of the patients.
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