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

Recruiting

• Conditions: Fatty Liver Disease

• Registration Number: NCT06720766
• Lead Sponsor: The Third People's Hospital of Chengdu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Cut-off values	Through study completion, an average of 1 year	Optimal thresholds for application on people with obesity

Trial Locations

Locations (1)

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