Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorThe Third People's Hospital of Chengdu

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • FibbroScan and biopsy

    Diagnostic test

    In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Diagnostic accuracy

Estimated using the area under the receiver operating characteristic curves for the categories of steatosis and fibrosis

Time frame
Through study completion, an average of 1 year
2

Cut-off values

Optimal thresholds for application on people with obesity

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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