3D-MRE and 2D-MRE for Assessing Cirrhosis and Portal Hypertension

China Medical University

Status: Enrolling

Conditions: Cirrhosis; Liver Portal Hypertension

Treatments: Device: HVPG; Device: 3D-MRE; Device: 2D-MRE

Study type: Observational

Funder types: Other

Identifiers

NCT06205992

ShengjingH2206

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age > 18 years old
2. confirmed cirrhosis (laboratory, imaging and clinical symptoms)
3. with 3D-MRE and 2D-MRE within 1 month prior to HVPG measurement
4. written informed consent

Exclusion criteria

1. any previous liver or spleen surgery
2. liver cancer; chronic acute liver failure
3. acute portal hypertension
4. unreliable HVPG, 3D-MRE or 2D-MRE results due to technical reasons
5. with liver interventional therapy between HVPG and MRE

Trial design

100 participants in 2 patient groups

Experimental group

Description:

Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE

Treatment:

Device: 3D-MRE

Device: HVPG

Device: HVPG

Control group

Description:

Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE

Treatment:

Device: 2D-MRE

Device: HVPG

Device: HVPG