Clinical trial NCT05532345: Discrimination of DILI and AIH by Artificial Intelligence
Official title: Development and Validation of a Machine Learning Model to Differentiate Drug-induced Liver Injury and Autoimmune Hepatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-induced Liver Injury
Autoimmune Hepatitis
Keywords: Artificial intelligence
Differential diagnose
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 2583
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients with a definite diagnosis of DILI and AIH were recruited from all hospitals between January 2009 to October 2022. This study was approved by the Institutional Ethical Review Board (2022-P2-263-01).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy of the model in the differential diagnosis of DILI and AIH
timeFrame: May 31, 2023
measure: The confidence of the model in the differential diagnosis of DILI and AIH
timeFrame: May 31, 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Xinyan Zhao, Dr.
role: STUDY_CHAIR
affiliation: The Fifth Medical Department of the PLA
name: Ying Sun, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University Affiliated Beijing You'an Hospital
name: Jing Zhang, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Second People's Hospital
name: Jia Li, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University Affiliated Second Hospital
name: Liang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heilongjiang provincial hospital
name: Xiaoli Hu, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Xiamen University
name: Jingshou Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
name: Feng Guo, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Qinghai People's Hospital
name: Pingying Li, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Qingdao University
name: Qiuju Tian, Dr.
role: PRINCIPAL_INVESTIGATOR
References: