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Diagnostic value and prognostic evaluation of imaging modality (CT, MRI) and serological biomarkers in hepatic sinusoidal obstruction syndrome induced by pyrrolidine alkaloid

Diagnostic value and prognostic evaluation of imaging studies (CT, MRI) and serological biomarkers in hepatic sinusoidal obstruction syndrome induced by pyrrolidine alkaloid

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DRD-17010709
Enrollment
Unknown
Registered
2017-02-23
Start date
2017-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Gold Standard:The clinical outcome will be the reference standard. The patients met the modified Seattle criteria1 for HSOS characterized by hyperbilirubinemia, hepatomegaly and weight gain due to flu
a Roussel Uclaf Causality Assessment Method (RUCAM) score= 5 (>3)
and a history of ingestion of Tusanqi.
Index test:hepatic&#32
patchy&#32
enhancement&#32
on&#32
CT&#32
or&#32
MRI
&#32
biomarkers&#32
of&#32
endothelial&#32
injure(protein&#32
C,&#32
antithrombin,&#32
plasminogen&#32
activator&#32
inhibitor-1)

Sponsors

Division of Gastroenterology, Union Hosptial, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: hepatic sinusoidal obstruction syndrome group: 1. Aged more than 18 years old; 2. a histoty of taking gynura segetum, especially tusanqi; 3. For HSOS, the patients satisfied the Seattle criteria. Two of three findings must occur. within 20 days of transplantation: billirubin >2mg/dL (1mg/dL=17.1umol/L); Hepatomegaly, right upper quadrant pain; Ascites with or without unexplained weight gain of >2% over baseline; 4. underwent CT scan or MRI scan. Budd-Chiari syndrome group: 1. Aged more than 18 years old; 2. radiology changes indicating of Budd-Chiari syndrome (ultrasound, CT, MRI; 3. confirmed by percutaneous angiography; 4. underwent CT scan or MRI scan.

Exclusion criteria

Exclusion criteria: hepatic sinusoidal obstruction syndrome group: 1. history of chronic liver diseases; 2. usage of the drugs that can iujure liver; 3. concurred with liver cancer, Budd-Chiari syndrome, congestive heart failure; 4. pregnant, mental disease. Budd-Chiari syndrome group: 1. concurred with liver cirrhosis or heart diseases; 2. Budd-Chiari syndrome caused by tumors; 3. pregnant, mental disease.

Design outcomes

Primary

MeasureTime frame
biomarkers of endothelial injure;Image feature of Contrast CT;Image feature of Contrast-enhanced MRI;—

Countries

China

Contacts

Public ContactYuhu Song

Union Hosptial, Tongji Medical College, Huazhong University of Science and Technology

yuhusong@163.com+86 15007187581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 28, 2026