CompletedNot Applicable

Discrimination of DILI and AIH by Artificial Intelligence

China2,583 participantsStarted 2022-07-01

Plain-language summary

A retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate Drug-induced liver injury and Autoimmune hepatitis. A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis

Who can participate

SexALL

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Inclusion criteria

✓. RUCAM ≥6 and met one of the following biochemical conditions: a.) ALT≥5 ULN, b.) or ALP ≥2 ULN, iii) or ALT≥3 ULN and TBil≥2 ULN.
✓. RUCAM was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility.
✓. The revised International Autoimmune Hepatitis Group (IAIHG) diagnostic score≥6 points.
✓. Liver biopsy available, which is compatible with typical features of AIH.
✓. If liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy.

Exclusion criteria

✕. Hepatotropic viral infection: hepatitis A, B, C, D and E.
✕. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
✕. Hypoxic ischemic hepatitis and congestive liver disease.
✕. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
✕. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
✕. Autoimmune hepatitis.
✕. Parasitic infection.
✕. Sepsis.

What they're measuring

Accuracy of the model in the differential diagnosis of DILI and AIH

Timeframe: May 31, 2023

The confidence of the model in the differential diagnosis of DILI and AIH

Timeframe: May 31, 2023

Trial details

NCT IDNCT05532345

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-05-31

View on ClinicalTrials.gov More Drug-induced Liver Injury trials