Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FibbroScan and biopsy.
- Who it may be relevant to
- Registry conditions: Fatty Liver Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test FibbroScan and biopsy
In individuals with obesity, a biopsy is performed within a week after undergoing an FibroScan examination.
Primary outcome measures
- Diagnostic accuracy [Time frame: Through study completion, an average of 1 year]
- Cut-off values [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Third People's Hospital of Chengdu — Chengdu
Identifiers
NCT: NCT06720766 · 2023-S-177 · CSY-YNXM-2023-001