The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:
• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.
Signed informed consent
Positive AMA (≥1:40 titer)
Persistently normal ALP
Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis
Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids
Contraindications for liver biopsy
Concomitant debilitating disease or poor prognosis
Adults aged 18-80 years with positive AMA and normal ALP
Case-only
Prospective
Not listed
Scheuer's criteria
Liver biopsy samples
Enhanced Liver Fibrosis (ELF) Score
Utilizes biomarkers such as hyaluronic acid, tissue inhibitor of metalloproteinase-1 (TIMP-1), and procollagen III amino-terminal peptide (PIIINP)
Fibroblast Growth Factor 19 (FGF-19)
Provides insights into bile acid regulation and metabolic liver function. Quantified using enzyme-linked immunosorbent assay (ELISA)
Tumor Necrosis Factor-alpha (TNF-α)
Measured via high-sensitivity ELISA to assess inflammatory status
Cytokine Profiling (Interleukin-6, -12, -23)
Serum cytokine levels will be determined using multiplex immunoassays
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