Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06720766

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot listed

ConditionFatty Liver Disease

Full registry criteria

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

Treatments and study arms

FibbroScan and biopsy

Diagnostic Test

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

Primary outcomes

Diagnostic accuracyThrough study completion, an average of 1 year

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

Cut-off valuesThrough study completion, an average of 1 year

Optimal thresholds for application on people with obesity

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Third People's Hospital of Chengdu🇨🇳 Chengdu, Sichuan, China

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Jiahui YuContact