A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 365
- Locations
- 1
- Primary Endpoint
- Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.
Study Overview
Brief Summary
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
Detailed Description
This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
- •Age over 18 years old, gender not limited;
- •Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
- •Perform iLivTouch examination within ± 14 days of liver pathology examination;
- •No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported