Diagnostic Efficacy of FibroScan for Liver Inflammation in CHB Patients: A Single-Center Study with 1,185 Liver Biopsies as Controls

Abstract

Background: It is important for chronic hepatitis B(CHB) to evaluate liver inflammation by noninvasive method. Fibroscan based on the transient elastography (TE) techniques is a noninvasive method widely used in the evaluation of liver fibrosis. We aimed to assess the efficacy of Fibroscan in the diagnosis of liver inflammation in patients with CHB. Methods: Ultrasound-guided liver biopsy was completed within one month after FibroScan testing in 1,185 CHB patients. Both the reliability criteria( interquartile range to median,IQR/M) of FibroScan and the quality of liver biopsy(complete portal tracts, CPTs) were well assured. The liver inflammation grading was classified into five grades (G0~G4).With liver biopsies as controls,the diagnostic efficacy of Fibsocan in the diagnosis of liver inflammation in CHB patients was evaluated by the receiver operating characteristic (ROC) curve. This study was registered with chictr.org.cn.This study was registered with chictr.org.cn, number ChiCTR-DRD-16009773. Findings: The liver stiffness measurement (LSM) reliability results of IQR/M were respectively 70% (IQR/M≤0.10),23% (0.100.10<IQR/M≤ 0.15),4% (0.15< IQR/M≤0.20),and 3% (0.20< IQR/M≤0.3). In theliver biopsy tissues, 977 cases (82%) had more than 10 CPTs and 208 cases (18%) had fewer than 10 CPTs.There were significant differences in LSM of FibroScan among different grades of liver inflammation (P<0.0001). With liver biopsy specimens containing more than 10 CPTs as controls, the cut-off point and the AUC of LSM of FibroScan in different inflammation grading were respectively G2(8.6kPa,0.775), G3(9.8kPa, 0.818),and G4(11.0kPa,0.832). Interpretation: FibroScan with LSM cut-off point of 8.6 kPa, 9.8 kPa and 11.0 kPa respectively had certain diagnostic value for CHB patients with liver inflammation of G2, G3 and G4, especially the inflammation of G4.It preliminarily showed that FibroScan could evaluate liver inflammation of CHB noninvasively. Funding: Foshan High Level Medical Key Discipline Construction Project and Peak Climbing Plan for Foshan High Level Hospital Construction. Declaration of Interest: All authors declare no competing interests. Ethical Approval: This study was approved by the ethics committee of Foshan Hospital of Traditional Chinese Medicine.