Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension: the Role of Contrast-enhanced Ultrasound and Splenic Elastography for Non-invasive Assessment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 107
- 主要终点
- Primary endpoint
研究概览
简要总结
Portal hypertension is a major complication of cirrhosis. HVPG is the diagnostic gold standard but is invasive. Non-invasive tools such as spleen stiffness measurement (SSM) and CEUS show promise for assessing CSPH, though they have not yet been compared directly. A multimodal ultrasound approach may provide a reliable alternative to HVPG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of both sexes aged 18 years or over; Subjects diagnosed with liver cirrhosis. Subjects who have undergone hepatic venous pressure gradient (HVPG) measurement to assess portal hypertension, and/or show indirect clinical signs of significant portal hypertension, such as oesophageal varices or porto-systemic collateral circulation.
- •Cirrhotic subjects who must undergo contrast-enhanced ultrasound as part of regular hepatological follow-up.
- •Subjects who have given their informed consent.
排除标准
- •Subjects aged under 18 years; Subjects with cholestatic disease Subjects diagnosed with clinically significant portal hypertension of non-cirrhotic aetiology.
- •Subjects diagnosed with ascites Subjects diagnosed with splanchnic thrombosis Subjects presenting with spleno-portal flow reversal Subjects who are allergic to ultrasound contrast media Subjects who have not given their informed consent.
研究组 & 干预措施
Cirrhosis
Adult participants (≥18 years old) with clinically confirmed liver cirrhosis, classified as Child-Pugh class A-C, with clinical and morphological signs of portal hypertension
干预措施: SonoVue (Drug)
结局指标
主要结局
Primary endpoint
时间窗: 12 months
evaluate the diagnostic performance between the selected parameters and the gold standard for assessing portal hypertension, i.e., HVPG using the ROC curve and calculation of sensitivity, specificity, VPP, VPN, and AUC. Bland-Altman analysis will be applied to assess concordance.
次要结局
- Secondary endpoint(12 months)
研究者
Pizzolante Fabrizio
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS