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

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.

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Key information

Conditions

Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Location status: Recruiting

Location contact

Jiahui Yu

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
Patients with haemochromatosis
Patients who have refused to undergo LB or blood tests
Patients with a confirmed diagnosis of active malignancy, or other terminal disease
Patients participating in another clinical trial within the preceding 30 days

Treatment and study plan

FibbroScan and biopsy

Diagnostic Test

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

Primary outcomes

Diagnostic accuracy

Time frame: 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
Cut-off values

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

Optimal thresholds for application on people with obesity

Study contacts

Contact information is provided by the study sponsor or research team.

Peisen Guo

CONTACT

[email protected]

+8615803838681

Sponsors and collaborators

Lead sponsor

The Third People's Hospital of Chengdu

Other

Registry information

Acronym: MASLD

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 6, 2024
Registry last updated: Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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