Evaluating FibroScan for Diagnosing Liver Disease in Obese Chinese Patients
Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
This study is testing how well FibroScan can help diagnose liver disease in obese Chinese patients by comparing its results to liver biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Third People's Hospital of Chengdu Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06720766 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of FibroScan, a non-invasive tool, in diagnosing metabolic associated fatty liver disease (MASLD) among Chinese individuals with obesity. It focuses on determining the optimal cut-off values for liver steatosis and fibrosis specifically tailored for this population. Participants will undergo both FibroScan examinations and liver biopsies to compare results and improve diagnostic accuracy. The study seeks to address uncertainties regarding confounding factors that may affect diagnosis in this demographic.
Who should consider this trial
Good fit: Ideal candidates include Chinese adults aged 18 and older who are scheduled for bariatric surgery and a liver biopsy due to suspected MASLD.
Not a fit: Patients with active malignancies, terminal diseases, or those who have undergone liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of liver disease diagnosis in obese Chinese patients, leading to better management and treatment outcomes.
How similar studies have performed: While the use of FibroScan is established, this specific application for the Chinese obese population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chengdu, Sichuan
- The Third People's Hospital of Chengdu — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Peisen Guo
- Email: peisenguo@163.com
- Phone: +8615803838681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.