Fatty Liver Disease
Conditions
Brief summary
The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity. The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.
Interventions
DIAGNOSTIC_TESTFibbroScan and biopsy
In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.
Sponsors
The Third People's Hospital of Chengdu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
1. Patients aged 18 years or older who provided written informed consent 2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD 3. Patients who schedule to undergo FibroScan examination
Exclusion criteria
1. Patients with ascites or pregnant women 2. Patients with any active implantable medical device (such as a pacemaker or defibrillator) 3. Patients who have undergone liver transplantation 4. Patients with cardiac failure and/or significant valvular disease 5. Patients with haemochromatosis 6. Patients who have refused to undergo LB or blood tests 7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease 8. Patients participating in another clinical trial within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cut-off values | Through study completion, an average of 1 year | Optimal thresholds for application on people with obesity |
| Diagnostic accuracy | Through study completion, an average of 1 year | Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis |
Countries
China
Contacts
Primary ContactPeisen Guo
Outcome results
None listed