Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)

Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)

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.

Inclusion Criteria:

• Signed informed consent
• Positive AMA (≥1:40 titer)
• Persistently normal ALP

Exclusion Criteria:

• 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
• Pregnancy