Assessment of FibroScan in the Diagnostic Efficacy of Liver Inflammation in Patients with Chronic Hepatitis B: A Single-Center Large Sample Study of 1185 Cases

Background: It is important for clinical diagnosis and therapeutic effect monitoring of 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.The reliability criteria of FibroScan detection are as follows:ratio of interquartile range (IQR) to median (M)( IQR/M) was less than 0.30 and took less than 0.10 as the best.Liver biopsy with a 18-gauge disposable needle made the extracted liver tissue longer than 1.5 cm, including at least 6 complete portal tracts (CPTs). Liver fibrosis staging（F1～F4）was performed according to METAVIR system and the liver inflammation grading was classified into five grades (G0～G4) according to the Scheuer scoring system.With liver biopsy as contrast,the diagnostic efficacy of Fibsocan in the diagnosis of liver inflammation in CHB patients was evaluated by the receiver operating characteristic(ROC) curve. Findings: The liver stiffness measurement(LSM) reliability results of IQR/M were respectively ≤0.10 (accounted for 70%),0.10～0.15 (accounted for 23%), 0.15～0.20 (accounted for 4%),and 0.20～0.30 (accounted for 3%). Among the liver biopsy tissues of 1185 patients with CHB, 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).The cut-off point and the AUC of LSM of FibroScan in different inflammation grading were respectivelyG2(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. Trial Registration: This study was registered with chictr.org.cn, number ChiCTR-DRD-16009773. Funding Statement: Foshan High Level Medical Key Discipline Construction Project and "Peak Climbing Plan" for Foshan High Level Hospital Construction (FSGSPZD135032). Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: The study protocol conformed to the ethical guidelines of the current declaration of Helsinki and approved by the ethics committee. All patients with CHB signed the informed consent for liver biopsy.