Ultrasound Score Combined with Liver Stiffness Measurement by Sound Touch Elastography for Staging Liver Fibrosis in Patients with Chronic Hepatitis B: a Clinical Prospective Study.

Background: A noninvasive and precise diagnosis of liver fibrosis in patients with chronic hepatitis B (CHB) is crucial for establishing the optimal time and strategy of therapy and for predicting treatment response. This study aimed to assess the diagnostic performance of ultrasound (US) score and liver stiffness measurement (LSM) of sound touch elastography (STE) in diagnosing liver fibrosis stages and to investigate whether combining these methods would improve liver fibrosis staging. Methods: US and STE examinations were performed in CHB patients included. Liver biopsy was used as a reference standard. A diagnostic marker with the optimal linear combination (LC) of US score and LSM of STE, namely LC marker, was established for noninvasive assessment of liver fibrosis stages. The diagnostic performance of the LC marker was evaluated by using receiver operating characteristic (ROC) curves and the area under the ROC curve (AUC). Results: A total of 291 subjects, including 242 patients with CHB and 49 healthy volunteers, were included. Correlation analysis showed that the correlation of liver fibrosis stages to the LC marker (Spearman's r=0.846, P<0.001) was higher than that of LSM (r=0.771, P<0.001) or US score (r=0.825, P<0.001) alone. The results showed that the overall diagnostic performance of the LC marker in predicting a fibrosis stage of >= F1, >= F2, >= F3 and =F4 {AUCs: 0.943 [95% confidence interval (CI): 0.917-0.948], 0.906 (0.871-0.915), 0.953 (0.923-0.969), and 0.961 (0.922-0.973), respectively} were better than those of the US score [AUCs: 0.916 (0.883-0.948, P=0.014), 0.875 (0.835-0.915, P<0.001), 0.934 (0.898-0.969, P=0.001), and 0.918 (0.864-0.973, P<0.001), respectively] or LSM [AUCs: 0.858 (0.812-0.948, P<0.001), 0.867 (0.826-0.915, P=0.006), 0.930 (0.894-0.969, P<0.023), and 0.958 (0.918-0.973, P=0.778), respectively]. Conclusions: The LC marker with the optimal combination of LSM and US score may be considered as a promising diagnostic model for noninvasive staging of liver fibrosis.