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Changes of liver reserve function in nonalcoholic fatty liver patients

Changes of liver reserve function in nonalcoholic fatty liver patients - Changes of liver reserve function in nonalcoholic fatty liver patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095512
Enrollment
Unknown
Registered
2025-01-08
Start date
2024-11-13
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Non-acholic fatty liver disease

Interventions

Gold Standard:Instantaneous elastic detector FibroTouch
Index test:Data obtained by instantaneous elastic ultrasound FibroTouch (CAP), liver hardness value (LSM), indocyanine green (indocyanine green) ICG clearance test data [Plasma ICG 15-minute retention

Sponsors

Kailuan General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. age: 18-75 years old; 2. history, clinical manifestations, signs, laboratory tests and other information is complete. 3. Meet the diagnostic criteria for NAFLD. 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1, male alcohol consumption per week >=210g, female alcohol consumption per week >=140g; 2, there are conditions that may lead to hepatic steatosis, such as the use of special drugs (tamoxifen, ethofurone, sodium valproate, methotrexate, glucocorticoids, etc.), total parenteral nutrition, inflammatory bowel disease, celiac disease, Cushing's syndrome, beta-lipoprotein deficiency, lipid atrophic diabetes, hypothyroidism, abdominal disease, and increased cortisol; 3. Patients with other liver diseases (hepatitis C virus infection, autoimmune hepatitis, hepatolenticular degeneration, etc.), malignant tumors, active infections, uremia and severe mental or cognitive impairment; 4. Pregnant or lactating women. 5, Indocyanine green (ICG) cleared the test contraindications in patients: 1) to iodine, shellfish, seafood food allergy, a history of severe allergy, anaphylactic shock. 2) Patients with uremia. 3) Patients with severe liver disease. 6. Patients with FibroTouch contraindications of instantaneous elastic detector: 1) Patients with implanted pacemaker, stent or other metal instruments. 2) Patients with ascites. 3) The skin at the test site has wound not closed. 4) Acute onset of hepatitis, cholestasis, liver edema or congestion. 5) Liver amyloidosis. 7. Unable or unwilling to sign the informed consent. 8. Other malignant diseases.

Design outcomes

Primary

MeasureTime frame
ICG-R15;ICG-K;CAP;LSM;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
ICG-R10;ICG-R5;Positive predicative value;Negative predictive value;

Countries

China

Contacts

Public ContactXiangming Ma

Kailuan General Hospital

maxiangming@tmu.edu.cn+86 133 3315 8299

Outcome results

None listed

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