Discrimination of DILI and AIH by Artificial Intelligence

Capital Medical University

Status: Completed

Conditions: Drug-induced Liver Injury; Autoimmune Hepatitis

Study type: Observational

Funder types: Other

Identifiers

NCT05532345

2022-P2-263-01

Details and patient eligibility

About

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

Full description

Research Objectives:

1. To develop a machine learning-based model from retrospective data.
2. To validate the machine learning-based model from internal dataset and external datasets nationwide.
3. To setup a website or application based on the above model to discriminate Drug-induced liver injury and Autoimmune hepatitis.

Enrollment: 2,583 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Drug-induced liver injury

  1. 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.
  2. RUCAM was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility.

• Autoimmune hepatitis

  1. The revised International Autoimmune Hepatitis Group (IAIHG) diagnostic score≥6 points.
  2. Liver biopsy available, which is compatible with typical features of AIH.
  3. If liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy.

Exclusion criteria

• Drug-induced liver injury

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Autoimmune hepatitis.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.

• Autoimmune hepatitis

  1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
  2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
  3. Hypoxic ischemic hepatitis and congestive liver disease.
  4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
  5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
  6. Drug-induced liver injury.
  7. Parasitic infection.
  8. Sepsis.
  9. Previous liver transplantation or bone marrow transplantation.
  10. Pregnancy or lactation.
  11. Genetic and metabolic liver diseases.

Trial design

2,583 participants in 3 patient groups

Development group, retrospectively collecting

Description:

The training set includes 80% of the development dataset from Beijing Friendship Hospital (Retrospectively collecting DILI 649 cases and AIH 180 cases in total)

Validation group, retrospectively collecting

Description:

The internal validation group includes 20% of the development dataset from Beijing Friendship Hospital (Retrospectively collecting DILI 649 cases and AIH 180 cases in total). External validation groups include Fifth Medical Center of Chinese PLA Medical Center(Retrospectively collecting DILI 585 cases and AIH 400 cases in total), Beijing You'an Hospital (Retrospectively collecting DILI 266 cases and AIH 100 cases in total) and additional seven tertiary hospitals throughout China (Retrospectively collecting DILI 182 cases and AIH 92 cases in total, including Tianjin Second People's Hospital, Heilongjiang Provincial Hospital, Affiliated Hospital of Qingdao University, the First Affiliated Hospital of Xiamen University, Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region, Lanzhou University Second Hospital, Qinghai Provincial People's Hospital).

Real-World validation group, prospectively and retrospectively collecting

Description:

Real-World validation data will be prospectively and retrospectively collected from Beijing Friendship Hospital (78 cases for DILI and 51 cases for AIH)