Evaluation of pCLE in the bile duct: final results of EMID study

Pre-operative histology of bile duct stenosis is associated with low accuracy. Probe confocal laser endomicroscopy (pCLE) enables optical biopsy or in vivo histology. The definitive results of the EMID study are presented here, comparing optical biopsies with definitive histology. Sixty one patients with a biliary stricture without any previous histology were included (July 2007–May 2012). An endoscopic ultrasound (EUS) had to be conducted before the ERCP procedure. pCLE was done using CholangioFlex during the ERCP procedure. Results were compared to those of definitive histology obtained by biopsy or surgery in case of malignant lesions, and by surgery or 1-year follow-up in case of benign lesions. Six patients were excluded because no definitive histology was available. There were 41 malignant lesions and 14 benign lesions. Sensitivity, specificity, PPV, NPV, and accuracy with combination of pCLE with endobiliary and EUS biopsies were 100, 71, 91, 100, and 93 %, respectively (with a significant increase of accuracy compared with endobiliary and EUS biopsies without pCLE, p= 0.03). 19 patients had a biliary stricture without individualized mass (6 malignant lesions, 13 benign lesions). Sensitivity, specificity, PPV, NPV, and accuracy for pCLE were 83, 77, 62, 91, and 79 %, respectively. Sensitivity, specificity, PPV, NPV, and accuracy for combination of pCLE with endobiliary and EUS biopsies were 100, 69, 60, 100, and 79 %, respectively. The addition of a pCLE procedure in the diagnostic histologic examination of a biliary stricture permits a significant increase in diagnostic reliability and allows for a VPN of 100 %.