Autoimmune Hepatitis, Drug-induced Liver Injury
Conditions
Keywords
Artificial intelligence, Differential diagnose
Brief 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
Detailed 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.
Interventions
None listed
Sponsors
Beijing Friendship Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the model in the differential diagnosis of DILI and AIH | May 31, 2023 | The ratio of the correct number of forecasts to the total number of forecasts |
| The confidence of the model in the differential diagnosis of DILI and AIH | May 31, 2023 | The confidence and 95% confidence internal of the model in determining whether each case is DILI or AIH |
Countries
China
Contacts
STUDY_CHAIRXinyan Zhao, Dr.
Beijing Friendship Hospital
PRINCIPAL_INVESTIGATORYing Sun, Dr.
The Fifth Medical Department of the PLA
PRINCIPAL_INVESTIGATORJing Zhang, Dr.
Capital Medical University Affiliated Beijing You'an Hospital
PRINCIPAL_INVESTIGATORJia Li, Dr.
Tianjin Second People's Hospital
PRINCIPAL_INVESTIGATORLiang Wang, Dr.
Lanzhou University Affiliated Second Hospital
PRINCIPAL_INVESTIGATORXiaoli Hu, Dr.
Heilongjiang Provicial Hospital
PRINCIPAL_INVESTIGATORJingshou Chen, Dr.
The First Affiliated Hospital of Xiamen University
PRINCIPAL_INVESTIGATORFeng Guo, Dr.
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
PRINCIPAL_INVESTIGATORPingying Li, Dr.
Qinghai People's Hospital
PRINCIPAL_INVESTIGATORQiuju Tian, Dr.
The Affiliated Hospital of Qingdao University
Outcome results
None listed