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Value of Pyrrole Protein Adducts for PA-induced Hepatic Sinusoidal Obstruction Syndrome in Patients with Unexplained Liver Injury

Value of Pyrrole Protein Adducts for PA-induced Hepatic Sinusoidal Obstruction Syndrome in Patients with Unexplained Liver Injury

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040862
Enrollment
Unknown
Registered
2020-12-12
Start date
2020-12-02
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

PA-HSOS

Interventions

Gold Standard:Original Nanjing Index: 1. A definite history of PA intake
2. Abdominal distention and/or hepatomegaly, liver pain, ascites
3. Abnormal liver function test
4. Typical characteristics of enhanced CT or MRI. 5.Pathologically confirmed diagnosis includes swelling, damage and shedding of hepatic sinusoidal endothelial cells&#32
Index test:1.&#32
of&#32
alkaloid&#32
protein&#32
and&#32
serum&#32
adduct)
&#32
2.&#32

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) Symptoms: including abdominal distension, jaundice, anorexia, oliguria, etc., with or without a history of pyrrole alkaloids medication; 2) Abnormal liver function (ALT > 40u/L, AST > 40u/L, or TB > 34umol/L); 3) Informed consent.

Exclusion criteria

Exclusion criteria: 1. There are contraindications for CT or MRI examination (such as renal insufficiency), which can not be evaluated by Nanjing standard; 2. There are many chronic liver damage factors (such as hepatophilic virus infection, long-term drinking history, cholestasis, autoimmune, etc.) in the past; 3. Participants in other clinical trials at the same time.

Design outcomes

Primary

MeasureTime frame
SEN, APE, ACC, AUC of ROC ;

Countries

China

Contacts

Public ContactZhuge Yuzheng

The Affiliated Drum Tower Hospital of Nanjing University Medical School

yuzheng9111963@aliyun.com+86 13770755008

Outcome results

None listed

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