跳至主要内容
临床试验/NCT06205992
NCT06205992招募中不适用

Three-dimensional MR Elastography and Two-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension:A Prospective Multicenter Study

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月16日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Shi

Deputy director of department of radology

Shengjing Hospital

研究点 (1)

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