NCT03548597已完成不适用
Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
European Georges Pompidou Hospital0 个研究点目标入组 132 人开始时间: 2012年4月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 主要终点
- Elasticity measured with the Fibroscan XL
研究概览
简要总结
Background:
The XL probe of FibroScan was recently developed to realize liver stiffness measurements (LSM) in overweight patients.
Severe obese patients have a high prevalence of liver injuries and could benefit of liver evaluation prior to bariatric surgery.
Objectives:
Assess the FibroScan applicability, reliability and diagnostic performances in severe obese patients' candidates for bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe obese patients candidate to bariatric surgery with no history of liver disease have a large prevalence of liver lesions.
排除标准
- 未提供
结局指标
主要结局
Elasticity measured with the Fibroscan XL
时间窗: 3 years
Liver elasticity will be measured non-invasively with Fibroscan. As this is a non-invasive measure, no adverse effects are expected. No treatment planned.
次要结局
- 53/5000 Evolution of elasticity after bariatric surgery(3 years)
研究者
Charles Barsamian
Doctor of Medicine
European Georges Pompidou Hospital
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