Endoscopic Ultrasound Share-wave for the Evaluation of Patients With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Correlation of EUS-share of the liver
研究概览
简要总结
Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions.
The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks.
Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis.
Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.
详细描述
A non-blinded, prospective trial. Primary disease condition: liver cirrhosis Keywords: Liver Cirrhosis; Fibrosis; Endoscopic Ultrasonography; Elasticity Imaging, Tissue.
Study Design: Observational study model: a non-blinded, non-randomized, prospective trial Time perspective: prospective Enrollment type: actual Number of subjects: 16 participants Number of groups/cohorts: 2 cohorts Target follow-up duration: 6 months
Based on the proportion of patients with the liver strain histogram (LSH) >87.40 among cirrhosis (87.5%) and control cases (31.0%) described by Robles-Medranda et al. (1), the investigators calculated eight patients per study group with a 5% and 20% of alpha and beta error respectively, with an 80% of power statistic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provided informed written consent
- •Age greater than 18 years of age
- •Confirmed diagnosis of chronic liver disease based on transient elastography
- •Patients with EUS-guided liver biopsy
排除标准
- •History of uncontrolled coagulopathy
- •Contraindications to EUS-guided liver biopsy
- •Pregnancy or nursing
- •History of hepatocellular carcinoma
- •Patients with equivocal transient elastography results
结局指标
主要结局
Correlation of EUS-share of the liver
时间窗: 2 months
Evaluation of the correlation between transient elastography, EUS-elastography of the liver, EUS-guided liver biopsy and EUS-guided share wave of the liver
Diagnostic accuracy of EUS-share wave of the liver
时间窗: 2 months
Evaluate the diagnostic accuracy of EUS- share wave of the liver for predicting liver cirrhosis. Receiver operating characteristic curve development with evaluation of the sensitivity, specificity, PPV and NPV of EUS-guided share wave of the liver to predict liver cirrhosis.
次要结局
未报告次要终点