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Multi-center study for liver stiffness measurement with ElastQ in chronic hepatitis and non-alcoholic fatty liver disease

Multi-center study for liver stiffness measurement with ElastQ in chronic hepatitis and non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029961
Enrollment
Unknown
Registered
2020-02-17
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-02-25

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

Conditions

Chronic hepatitis B, Nonalcoholic fatty liver disease

Interventions

Gold Standard:Liver histopathology
Index test:ElastQ

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. CHB: Those who had a history of hepatitis B or had positive HBsAg for more than 6 months, but still had positive HBsAg and/or HBV-DNA. 3. NAFLD: (1) Imaging evidence of diffuse hepatocellular fatty change; (2) No history of excessive drinking (less than 30 g/d for men and less than 20 g/d for women); (3) Except alcoholic liver disease (ALD), genotype 3 HCV infection, autoimmune hepatitis, liver bean-like nuclear degeneration, etc, excluding drugs (hemoxifen, amine iodedone, sodium acetate, methotrexate, glucocorticoids, etc.), whole gastrointestinal nutrition, inflammatory bowel disease, celiac, hypothyroidism, Cushing syndrome, beta lipoprotein deficiency emias, lipid atrophy diabetes, Mauriac syndrome, etc.; (4) No specific symptoms and signs, patients can appear serum ALT and GGT increase.

Exclusion criteria

Exclusion criteria: (1) Patients received liver transplantation (2) Pregnant or lactating women (3) Patients with severe pulmonary insufficiency and respiratory incompatibility (4) Patients with obesity (BMI > 30kg/m2, male abdominal circumference > 90cm, female abdominal circumference > 90cm) and difficulty in penetrating elastic shear wave (5) Complicated with other liver diseases such as hepatic vein embolism, intrahepatic bile duct dilatation or biliary obstruction (6) Patients with unstable clinical state, advanced disease or unpredictable clinical course (7) Patient without pathological diagnosis

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;ACC;AUC of ROC;

Countries

China

Contacts

Public ContactLuo Yan

Department of Ultrasound, West China Hospital, Sichuan University

luoyan77@163.com+86 18980601605

Outcome results

None listed

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