3D-MRE for Assessing Cirrhosis and Portal Hypertension

Study Overview
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Brief Summary
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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 investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.

Detailed Description
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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. Multiparametric three-dimensional (3D) MR elastography allows for basic viscoelastic modeling of tissue, partitioning the complex shear modulus into elastic components (eg, storage modulus) and viscous components (eg, loss modulus and damping ratio [DR]). 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. We 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 investigate the ability of three demensional-magnetic resonance elastography (3D-MRE) to establish a risk stratification system and perform tailored management for portal hypertension in cirrhosis.

Official Title
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Three-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension (CHESS2206): A Prospective Multicenter Study

Conditions
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Cirrhosis, Liver, Portal Hypertension

Intervention / Treatment
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* Device: 3D-MRE
* Device: HVPG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years old confirmed cirrhosis (laboratory, imaging and clinical symptoms) with 3D-MRE within 1 month prior to HVPG measurement written informed consent Exclusion Criteria: any previous liver or spleen surgery liver cancer; chronic acute liver failure acute portal hypertension unreliable HVPG or 3D-MRE results due to technical reasons with liver interventional therapy between HVPG and 3D-MRE

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training cohort<br>Training cohort was set to develop the novel non-invasive model for virtual HVPG | Device: 3D-MRE<br>* All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.<br>Device: HVPG<br>* HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.<br>|
| Validation cohort<br>Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments | Device: 3D-MRE<br>* All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.<br>Device: HVPG<br>* HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the features of 3D-MRE for assessing portal hypertension in cirrhosis. | WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE was assessed. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D-MRE, HVPG