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Metabolomics Characteristics of Pyrrolidine Alkaloid-related Hepatic Sinusoidal Obstruction Syndrome: A Multicenter Observational Study

Metabolomics Characteristics of Pyrrolidine Alkaloid-related Hepatic Sinusoidal Obstruction Syndrome: A Multicenter Observational Study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072762
Enrollment
Unknown
Registered
2023-06-25
Start date
2023-06-30
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic sinusoidal obstruction syndrome

Interventions

PA-HSOS:None
Other liver diseases:None

Sponsors

The Affiliated Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Healthy physical examination population: (1) At the time of signing the informed consent form, the patients were over 18 years old (including 18 years old) and under 85 years old (including 85 years old); (2) The two halves of hepatitis B (quantitative), liver function, and color Doppler ultrasound results of liver, gallbladder, spleen and pancreas were normal in the health examination package. (3) Completed the reference individual inquiry questionnaire and the evaluation result is normal; (4) No clinical symptoms such as abdominal distension and/or pain in the liver region, hepatomegaly, ascites, and jaundice; (5) No history of liver disease (including hepatitis, liver cancer and other liver diseases) 2. Patients with pyrrolidine alkaloid-related hepatic sinusoidal obstruction syndrome (PA-HSOS) : (1) At the time of signing the informed consent form, the patients were over 18 years old (including 18 years old) and under 85 years old (including 85 years old); (2) Meeting the "Nanjing Criteria" for the diagnosis of PA-HSOS. 3. Patients with other liver diseases: (1) At the time of signing the informed consent form, the patients were over 18 years old (including 18 years old) and under 85 years old (including 85 years old); (2) Clinically confirmed patients with other liver diseases other than pyrrolidine alkaloid-related sinusoidal obstruction syndrome (PA-HSOS); Such as Budd-Chiari syndrome, cirrhosis, viral hepatitis, autoimmune liver disease, liver malignant tumor, alcoholic liver injury, acute severe hepatitis, metabolic-associated fatty liver disease (MAFLD), other drug-induced liver injury (RUCAM=3), other HSOS.

Exclusion criteria

Exclusion criteria: 1. Health physical examination population: (1) Abnormal liver function tests (ALT>40U/L, AST>40U/L or total bilirubin>34µmol/L). (2) Clinical symptoms such as abdominal distension and/or pain in the hepatic region, hepatomegaly, ascites, and jaundice; (3) Liver injury caused by any cause; (4) Abnormal results of color Doppler ultrasound of liver, gallbladder, spleen and pancreas; (5) PA-HSOS patients diagnosed according to the "Nanjing Criteria"; (6) Heavy drinking, alcohol consumption =40g/d (male), =20g/d (female) for more than 5 years or =80g/d within 2 weeks; (7) Taking any known hepatotoxic drugs, such as non-steroidal anti-inflammatory drugs, antibiotics, anticonvulsants and psychotropic synthetic drugs; (8) Taking Chinese medicine/patent Chinese medicine containing PA orally or topically for any reason; (9) Pregnant and lactating women; (10) Unable to complete the reference individual inquiry questionnaire or samples with incomplete or untraceable original information; (11) Other situations where the investigator considers that the subject should not participate in the study. 2. Patients with pyrrolidine alkaloid-related hepatic sinusoidal obstruction syndrome (PA-HSOS) : (1) No history of taking PA containing herbal medicine; (2) Unable to provide the detailed information of the drugs taken, such as the name of the drug, the time of taking the drug and the time of stopping the drug; (3) Do not meet the "Nanjing Criteria" for the diagnosis of PA-HSOS; (4) Pregnant and lactating women; (5) The original information of the sample is incomplete or untraceable; (6) Other situations where the investigator believes that the subject should not participate in the study. 3. Patients with other liver diseases: (1) PA-HSOS patients were diagnosed according to the "Nanjing Criteria"; (2) Pregnant and lactating women; (3) Failure to provide detailed case records or incomplete or untraceable original information of samples; (4) Patients with other drug-induced liver injury could not provide detailed drug information, such as drug name, medication time and withdrawal time; (5) Other situations where the researcher thinks that the subject should not participate in the study.

Design outcomes

Primary

MeasureTime frame
Concentration of PPAs;

Countries

China

Contacts

Public ContactYuzheng Zhuge

The Affiliated Drum Tower Hospital of Nanjing University Medical School

yuzheng9111963@aliyun.com+86 159 9628 9206

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026