Tomotake, Koizumi, Division of Gastroenterological and General Surgery, Department of Surgery, School of Medicine, Showa University, Japan.

•The present study used resected benign and malignant gallbladder specimens, sprayed with fluorescein and imaged with pCLE, to visualize structures that accurately determined gallbladder malignancy.

•A total of 73 patients had their gallbladder evaluated with pCLE performed on resected benign and malignant gallbladder surgical specimens, which were sprayed with fluorescein. Malignant and benign features of pCLE findings were identified on the basis of Miami and Paris Classifications. Standard histopathological diagnoses and individual patient pCLE findings of gallbladder lesions were correlated.

•Of the 73 consecutive patients that had their gallbladder evaluated ex vivo with pCLE, 11 were
identified with gallbladder malignancy. pCLE identified features of gallbladders examined ex vivo, including the presence of thick dark bands and dark clumps, which together correlated with histopathologically-determined biliary malignancy at 100% sensitivity. Thick white bands and visualized epithelium, also identified with pCLE, together correlated with histopathologically-determined malignancy at 100% specificity.

•pCLE can be used for real-time differentiation of cancerous/non-cancerous regions in the gallbladder using the diagnostic criteria identified in the present study.