Immunological Measurement of Aspartate/Alanine Aminotransferase
- Conditions
- Chronic Liver Disease and Cirrhosis
- Interventions
- Diagnostic Test: with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
- Registration Number
- NCT03562585
- Lead Sponsor
- Chuncheon Sacred Heart Hospital
- Brief Summary
Previous reports have suggested that ALT-immunoglobulin complex was increased according to the severity of the liver disease, and high concentration of mAST and this might indicate a severely damaged liver. Immunoassay might be useful as a screening method in the differ-ential diagnosis of liver fibrosis according to patients. In this study, the efficacy of immunoas-say in the prediction of liver fibrosis in patients with chronic hepatitis B (CHB) was evaluated.
- Detailed Description
Enzymatic analysis of aspartate/alanine aminotransferase (AST/ALT) does not exactly represent the progression of liver fibrosis. Immunoassay for the AST (cytoplasmic \[c\] AST/mitochondrial \[m\] AST) and ALT (ALT1/ALT2) have been suggested as one of the alternatives for the enzy-matic analysis. We evaluated the efficacy of immunoassay in predicting liver fibrosis and in-flammation. A total of 219 patients with chronic hepatitis B (CHB) who underwent hepatic ve-nous pressure gradient (HVPG) and liver biopsy before antiviral therapy were recruited. Serum samples were prepared from blood during HVPG. The liver function test including enzymatic AST/ALT and immunological cAST, mAST, ALT1 and ALT2 were checked with sandwich ELI-SA immunoassay with fluorescence labeled monoclonal antibodies, and were compared with the METAVIR stage of live fibrosis and the Knodell grade of inflammation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
- patients with CHB, who simultaneously underwent HVPG and liver biopsy for the routine check-up prior to antiviral treatment, were prospectively recruited.
- Patients were selected according to inclusion criteria with CHB and then excluded according to exclusion criteria: i. they had other cause with liver disease: ii. decompensated cirrhosis and re-ceived antiviral treatment within the previous 6 months. iii. malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Efficacy of immunoassay in liver fibrosis with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies efficacy of immunoassay in liver fibrosis in patients with CHB
- Primary Outcome Measures
Name Time Method A sandwich enzyme immune-assay (ALT1, ALT2, mAST, cAST) according to fibrosis and inflammation 3 years efficacy of immunoassay in predicting liver fibrosis and inflammation.
- Secondary Outcome Measures
Name Time Method HVPG score 3 years efficacy of HVPG in predicting liver fibrosis and inflammation.