Clinical utility of FibroScan as a non‐invasive diagnostic test for primary biliary cholangitis.

Background and Aim: Primary biliary cholangitis (PBC) is a chronic, slowly progressive, autoimmune liver disease. Some PBC patients display disease progression regardless of medical treatment. Therefore, it is important to accurately diagnose the clinical stage of PBC. This study investigated clinical merits of vibration‐controlled transient elastography using FibroScan for assessing disease stage in PBC. Methods: A total of 74 treatment‐naïve PBC patients (84% female, median age: 64 years), 69 of whom having undergone histological assessment and five clinically diagnosed as at the cirrhosis stage, were enrolled for clinical comparisons of liver stiffness measurement (LSM) with other established indices. Results: The number of patients with Nakanuma stages 1, 2, 3, and 4 was 18, 33, 17, and 6, respectively. The median LSM values for Nakanuma stages 1, 2, 3, and 4 were 5.05, 5.90, 8.90, and 23.70 kPa, respectively, and correlated significantly with disease progression based on Nakanuma's classification (r = 0.501, P < 0.001). LSM was also significantly related to other non‐invasive serological markers (Mac‐2 binding protein glycosylation isomer: r = 0.606, FIB‐4 index: r = 0.493, and aspartate aminotransferase‐to‐platelet ratio index: r = 0.577; all P < 0.001). The areas under the receiver operating characteristic curve for diagnosing Nakanuma stage ≥ 2, stage ≥ 3, and stage 4 were 0.744, 0.763, and 0.907, respectively. A combination of LSM ≥ 7.0 kPa and Mac‐2 binding protein glycosylation isomer ≥ 1.00 cut‐off index could predict late‐stage PBC (i.e. moderate to advanced disease progression) with a sensitivity of 0.58, specificity of 0.82, and accuracy of 0.74. Conclusions: Liver stiffness measurement using FibroScan provided simple, accurate, and non‐invasive assessment of disease stage in PBC patients. [ABSTRACT FROM AUTHOR]