Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diagnostic accuracy
时间窗: 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
时间窗: Through study completion, an average of 1 year
Optimal thresholds for application on people with obesity
次要结局
未报告次要终点
研究者
Hongmei Zhu
Assistant Researcher
The Third People's Hospital of Chengdu