Staging liver fibrosis in patients with chronic hepatitis B using two-dimensional shear wave elastography based on histopathological findings: a prospective multicenter study.

Abstract

With the rapid development of shear wave elastography technology, the clinical application prospect of two-dimensional shear wave elastography (2D SWE) for non-invasive monitoring of liver fibrosis is extremely promising. This study aimed to evaluate the diagnostic performance of ElastQ, a noval 2D SWE method, in the staging of liver fibrosis in patients with chronic hepatitis B with histopathological results as the reference standard. Between August 2020 and December 2021, a prospective multicenter study of 602 consecutive patients with chronic hepatitis B was conducted in 14 hospitals. All patients underwent liver biopsy and 2D SWE examination. The patients were divided into a training cohort and a validation cohort. The area under the receiver operating characteristic curve (AUROC) was calculated, and the optimal cut-off values for ElastQ were obtained. Overall, 2D SWE values showed a strong correlation with fibrosis stage (r=0.71, P<0.001). In the training cohort, the AUROCs of ElastQ for diagnosing fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 0.817 [95% confidence interval (CI): 0.777-0.853), 0.887 (95% CI: 0.852-0.915), 0.912 (95% CI: 0.881-0.937), and 0.832 (95% CI: 0.793-0.866)], respectively. In the validation cohort, the AUROCs of ElastQ for diagnosing fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 0.807 (95% CI: 0.742-0.861), 0.868 (95% CI: 0.810-0.914), 0.855 (95% CI: 0.796-0.903), and 0.851 (95% CI: 0.791-0.900), respectively. The optimal liver stiffness cut-off values for the identification of fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 5.72 kPa (sensitivity: 78%, specificity: 70%), 6.85 kPa (sensitivity: 77%, specificity: 86%), 7.43 kPa (sensitivity: 80%, specificity: 86%), and 8.03 kPa (sensitivity: 81%, specificity: 73%), respectively. Two-dimensional SWE can accurately stage liver fibrosis in patients with chronic hepatitis B.