About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older who provided written informed consent
Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
Patients who schedule to undergo FibroScan examination
Disqualifiers
Patients with ascites or pregnant women
Patients with any active implantable medical device (such as a pacemaker or defibrillator)
Patients who have undergone liver transplantation
Patients with cardiac failure and/or significant valvular disease
Trial population
The study population consisted of patients aged 18 years or older who provided written informed consent and were scheduled to undergo bariatric surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
FibbroScan and biopsy
Diagnostic testIn individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy
Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis
Cut-off values
Optimal thresholds for application on people with obesity
Sponsors and contacts
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