Role of 2D-shear Wave Spleen Elastography in Assessing Clinically Significant Portal Hypertension and High-risk Varices in Patients With Advanced Compensated Chronic Liver Disease.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- CSPH
研究概览
简要总结
The primary objective of this study is to evaluate the role of spleen shear wave elastography (SWE-SSM) for ruling in and ruling out clinically significant portal hypertension (CSPH) in patients with compensated advanced chronic liver disease (cACLD) and for ruling in and ruling out high-risk esophageal varices (HRV) in patients with CSPH. Secondary objectives of the study include the investigation of the correlation between SWE-SSM and portal pressure in a subgroup of patients undergoing hepatic venous pressure gradient (HVPG) measurement and between SWE-SSM and transient elastography (TE-SSM).
The values of SWE-SSM and SWE-LSM will be assessed during the ultrasound examination to which the patient will be subjected according to their care pathway. If inclusion criteria are met and informed consent is obtained, spleen elastography will be carried out (in addition to the routine SWE-LSM planned in clinical practice). Spleen elastography will not alter the standard ultrasound examination but represents a non-invasive diagnostic addition.
There will be no treatment or experimental intervention that will modify the patient's condition or directly influence their clinical course. The aim is to collect data based on clinical observations without altering the treatment or the natural course of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Age greater than 18 years;
- •SWE-LSM ≥9 kPa and/or TE-LSM ≥15 kPa;
排除标准
- •Presence of transjugular intrahepatic porto-systemic shunt (TIPS);·
- •Surgical absence of the spleen;
- •Grade 3 ascites;
- •History of variceal bleeding;
- •Refusal to participate in the study.
结局指标
主要结局
CSPH
时间窗: 2 years
The following data will be collected: * Shear Wave Elastography of the spleen (SWE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Shear Wave Elastography of the liver (SWE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Transient Elastography of the spleen (TE-SSM): continuous variable, expression of splenic stiffness, measured in kPa; * Transient Elastography of the liver (TE-LSM): continuous variable, expression of hepatic stiffness, measured in kPa; * Bipolar diameter of the spleen: measured in centimeters * Ascites yes/no; * Collateral circulation yes/no; * Encephalopathy yes/no; * Non selective beta-blockers yes/no; * Hepatic Venous Pressure Gradient (HVPG): continuous variable, portosystemic pressure gradient, measured in mmHg.
次要结局
- HRV(2 years)
研究者
Garcovich Matteo
Doctor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
