Could Serum Laminin Replace Liver Biopsy as Gold Standard for Predicting Significant Fibrosis in Patients with Chronic Hepatitis B? Clinical and Histopathological Study

Background: The prognosis and clinical treatment of chronic liver disease depends greatly on the progression of liver fibrosis, which has resulted from the loss of normal liver cell function due to disorganized over-accumulation of extra-cellular matrix (ECM) components in the liver. Liver biopsy has been considered the gold standard for staging and grading hepatic fibrosis and inflammation. However, the procedure is associated with complications such as bleeding, infection, damage to liver tissue, and it is difficult to put into practice. Aim of the work: To evaluate the diagnostic performance of serum laminin (LN) as serum markers for predicting significant fibrosis in chronic hepatitis B (CHB) patients. Subjects and methods: The study included 50 subjects, selected to represent 2 groups: group (I) included 30 patients with chronic hepatitis B who were diagnosed by positive serologic tests for serum hepatitis B surface antigen for at least 6 months and group (II) included 20 blood donors subjects who had no symptoms suggestive of liver diseases and negative serologic tests for serum hepatitis B surface antigen served as control. All participants were subjected to thorough history taking, physical examination and routine laboratory investigations include liver function tests. Serum laminin levels were assayed by radio immune assay (RIA). Liver biopsies were done to all chronic hepatitis B patients. Liver fibrosis stages were determined according to the Metavir scoring-system .Results: Serum LN concentrations increased significantly with the stage of hepatic fibrosis, which showed positive correlation with the stages of liver fibrosis (r = 0.591, p < 0.001). There were significant differences of serum LN levels between F2-4 groups (patients with significant fibrosis) in comparison with those in F0-F1 groups (mean values ± SD were 156.4 ± 53.8 vs 90.9 ± 20.1 ,p < 0.001). Serum LN at value 107.5ng/ml was the optimal cut-off value for diagnosis of significant fibrosis (sensitivity, specificity, positive predictive and negative predictive values were 84.2%, 63.6%, 80%, and 70.0%, respectively). Conclusion: Liver biopsy will remain gold standard for staging and grading hepatic fibrosis and inflammation. But LN could be clinically useful serum markers for predicting significant fibrosis in patients with chronic hepatitis B, especially when liver biopsy is contraindicated. Further studies are needed for determining its value in other chronic liver diseases such as chronic hepatitis C (CHC) and non alcoholic fatty liver disease (NAFLD), its use as marker of success of management and regression of fibrosis and clinical validity in comparison to other non invasive serum markers.