Three-dimensional MR Elastography and Two-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension:A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis.
研究概览
简要总结
How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of hepatic venous pressure gradient (HVPG) is an important general problem in the management of portal hypertension in cirrhosis. We plan to compare the ability of three demensional-magnetic resonance elastography (3D-MRE) to two demensional-magnetic resonance elastography (2D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.
详细描述
China suffers the heaviest burden of liver disease in the world. The number of chronic liver disease is more than 400 million. Either viral-related hepatitis, alcoholic hepatitis, or metabolic-related fatty hepatitis, etc. may progress to cirrhosis, which greatly threatens public health. Portal hypertension is a critical risk factor that correlates with clinical prognosis of patients with cirrhosis. According to the Consensus on clinical application of hepatic venous pressure gradient in China (2018), hepatic venous pressure gradient (HVPG) greater than 10,12,16,20 mmHg correspondingly predicts different outcomes of patients with cirrhosis portal hypertension. It is of great significance to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis. As a universal gold standard for diagnosing and monitoring portal hypertension, HVPG remains limitation for clinical application due to its invasiveness. How to construct a novel, non-invasive, accurate, and convenient method to achieve prediction of HVPG is an important general problem in the management of portal hypertension in cirrhosis. MR elastography allows for basic viscoelastic modeling of tissue, partitioning the complex shear modulus intoelastic components (eg, storage modulus) and viscous components (eg, lossmodulus and damping ratio [DR]). In previous studies, scholars have studied 2d MR elastography in cirrhosis to identify specific hepatic pathophysiologic interrelations. However, these mechanical properties of tissue measured with use of 3D MR elastography have yet to be investigated in cirrhosis to identify specific hepatic pathophysiologic interrelations. The investigators hypothesize that these mechanical properties might be valid presumptive surrogates of cirrhosis and portal hypertension, perhaps capable of supplanting liver biopsy or other invasive diagnostic interventions. This project aims to compare the ability of three demensional-magnetic resonance elastography (3D-MRE) to two demensional-magnetic resonance elastography (2D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years old
- •confirmed cirrhosis (laboratory, imaging and clinical symptoms)
- •with 3D-MRE and 2D-MRE within 1 month prior to HVPG measurement
- •written informed consent
排除标准
- •any previous liver or spleen surgery
- •liver cancer; chronic acute liver failure
- •acute portal hypertension
- •unreliable HVPG, 3D-MRE or 2D-MRE results due to technical reasons
- •with liver interventional therapy between HVPG and MRE
研究组 & 干预措施
Experimental group
Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE
干预措施: 3D-MRE (Device)
Experimental group
Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE
干预措施: HVPG (Device)
Control group
Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE
干预措施: 2D-MRE (Device)
Control group
Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE
干预措施: HVPG (Device)
结局指标
主要结局
Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis.
时间窗: 12 months
WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE and 2D-MRE was compared.
次要结局
未报告次要终点
研究者
Yu Shi
Deputy director of department of radology
Shengjing Hospital
