Evaluation of Shear Wave Elastography along with Biomarker Parameters as an Algorithm for Early Detection of Liver Fibrosis in Type 2 Diabetes Mellitus and Alcohol Abuse Patients

Abstract

Introduction: Hazardous alcohol use and diabetes are the major risk factors for development of liver cirrhosis. The presence and progression of hepatic fibrosis into cirrhosis is a prognostic variable having impact on survival in people with hazardous alcohol use and Type 2 Diabetes Mellitus. Liver biopsy is an invasive method for diagnosis and staging of hepatic fibrosis. Shear Wave Elastography (SWE) is a non-invasive method for assessing and staging hepatic fibrosis. Aim: To evaluate SWE as a non-invasive technique along with biomarker parameters as an algorithm for early detection of liver fibrosis in Type 2 Diabetes and hazardous alcohol use patients and to compare the results of shear wave ultrasound elastography in liver fibrosis with AST/ALT ratios, AST Platelet Ratio Index (APRI scores), and Fibrosis-4 (FIB-4) scores. Materials and Methods: A prospective cross-sectional study was conducted in a tertiary care hospital attached to Mysore Medical College and Research Institute, Mysore, Karnataka, India, from July 2018 to June 2019. Based on inclusion and exclusion criteria 460 patients were recruited for the study. For each patient, AST, ALT, platelet count and SWE values were measured. Patients with normal serum biomarkers and elevated SWE results were subjected to liver biopsy to confirm the diagnosis. Student’s t-test, Analysis of Variance (ANOVA), Chi-square/fisher-exact test was used to find the significance of study parameters. ANOVA was used to compare the SWE findings with the biochemical parameters. Results: SWE identified 75 patients with normal values, 2.2 m/sec (Group C). SWE showed positive correlation with APRI (p<0.001, r-0.464); AST/ALT ratio (p<0.001, r-0.462); AST (p<0.001, r-0.479); ALT (p<0.001,r-0.321) and FIB-4 (p<0.001, r-0.409). Forty seven patients with normal serum biomarkers levels and elevated SWE results, were advised liver biopsy. Twenty three patients who underwent successful liver biopsy at a cut-off value of 1.9 m/sec for significant fibrosis, the Area Under the Receiver Operating Characteristics (AUROC) was 0.793 and elastography had 71% sensitivity and 90% specificity. Conclusion: Incorporating SWE and liver enzyme assay as a non-invasive algorithm in routine helps in detection of a large number of previously undisclosed, significant chronic liver disease cases. This novel diagnostic approach resulted in increased detection of asymptomatic but clinically significant liver disease cases as compared to traditional liver enzymebased algorithms. SWE along with liver enzymes assay as an algorithm can replace 80% of liver biopsies within a community setting.

Keywords

• alcoholic liver disease
• liver fibrosis
• early diagnosis
• non-invasive method
• medical and economic impact