Discrimination of DILI and AIH by Artificial Intelligence
NCT ID: NCT05532345
Last Updated: 2023-07-21
Study Results
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Basic Information
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COMPLETED
2583 participants
OBSERVATIONAL
2022-07-01
2023-05-31
Brief Summary
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A machine learning-based tool will be developed and validated to help clinicians to differentiate between Drug-induced liver injury and Autoimmune hepatitis
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Development group, retrospectively collecting
The training set includes 80% of the development dataset from Beijing Friendship Hospital (Retrospectively collecting DILI 649 cases and AIH 180 cases in total)
No interventions assigned to this group
Validation group, retrospectively collecting
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).
No interventions assigned to this group
Real-World validation group, prospectively and retrospectively collecting
Real-World validation data will be prospectively and retrospectively collected from Beijing Friendship Hospital (78 cases for DILI and 51 cases for AIH)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Beijing Friendship Hospital
OTHER
Responsible Party
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Principal Investigators
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Xinyan Zhao, Dr.
Role: STUDY_CHAIR
Beijing Friendship Hospital
Ying Sun, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Fifth Medical Department of the PLA
Jing Zhang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Capital Medical University Affiliated Beijing You'an Hospital
Jia Li, Dr.
Role: PRINCIPAL_INVESTIGATOR
Tianjin Second People's Hospital
Liang Wang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Lanzhou University Affiliated Second Hospital
Xiaoli Hu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Heilongjiang provincial hospital
Jingshou Chen, Dr.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Xiamen University
Feng Guo, Dr.
Role: PRINCIPAL_INVESTIGATOR
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Pingying Li, Dr.
Role: PRINCIPAL_INVESTIGATOR
Qinghai People's Hospital
Qiuju Tian, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Qingdao University
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Countries
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References
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Wang Y, Lin X, Sun Y, Liu J, Li J, Tian Q, Guo F, Hu X, Wang L, Li P, Chen J, Wang Y, Ma Z, Jia J, Zhang J, Zou Z, Zhao X. Development and Validation of a Novel Model to Discriminate Idiosyncratic Drug-Induced Liver Injury and Autoimmune Hepatitis. Liver Int. 2025 Feb;45(2):e16239. doi: 10.1111/liv.16239.
Other Identifiers
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2022-P2-263-01
Identifier Type: -
Identifier Source: org_study_id
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