Real-world performance of transient elastography in assessing advanced fibrosis in Chinese patients with primary biliary cholangitis

Abstract

BACKGROUND

There is insufficient evidence on the evaluation of liver fibrosis in Asian individuals with primary biliary cholangitis (PBC) using vibration-controlled transient elastography (VCTE).

AIM

To assess advanced fibrosis (AF) using liver stiffness measurement (LSM) in Chinese patients with PBC.

METHODS

In total, 277 Chinese patients diagnosed with PBC who underwent liver biopsy and VCTE were retrospectively included and categorized into the derivation and validation cohorts. The areas under the receiver operating characteristic curves (AUROCs) with 95% confidence intervals (CIs) were used to estimate the diagnostic accuracy of LSM for AF (Ludwig stage ≥ III). Multivariable analysis was performed using logistic regression.

RESULTS

In the derivation cohort, VCTE accurately detected patients with AF, achieving an AUROC of 0.93 (95%CI: 0.88-0.96). AF was independently predicted by LSM according to multivariable analysis. AF can be excluded and confirmed using LSM cutoffs of ≤ 10.0 and > 14.5 kPa, respectively, with a sensitivity of 0.91, negative predictive value of 0.93, specificity of 0.96, positive predictive value of 0.92, and an error rate of 7.5%. The accuracy of these values was validated in an independent cohort, achieving an AUROC of 0.97 (95%CI: 0.90-0.99) for AF with a sensitivity of 0.89, negative predictive value of 0.88, specificity of 0.95, positive predictive value of 0.94, and error rate of 9.0%. Compared with serum fibrosis markers, the AUROC of LSM was significantly higher in both the derivation and validation cohorts.

CONCLUSION

VCTE has a high accuracy for assessing AF in Chinese patients with PBC in a real-world setting.

Keywords: Primary biliary cholangitis; Vibration-controlled transient elastography; Fibroscan; Liver stiffness measurement; Liver fibrosis; Chinese patients

Core Tip: This study retrospectively used vibration-controlled transient elastography (VCTE) to assess advanced fibrosis using liver stiffness measurement (LSM) in Chinese patients with histologically verified primary biliary cholangitis (PBC). To our knowledge, this study is currently the largest sample size among similar studies exploring VCTE for evaluating PBC fibrosis. Furthermore, this study provides a dual cut-off approach utilizing LSM through VCTE to categorize individuals with PBC into three categories of risk: Early-stage (LSM ≤ 10.0 kPa), advanced-stage (LSM > 14.5 kPa), and a grey area of inaccurate discrimination. This non-invasive method of individual risk stratification for PBC will aid in the selection of clinical decisions.