Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06205992
Enrollment
100
Registered
2024-01-16
Start date
2022-08-16
Completion date
2026-12-01
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver Portal Hypertension

Keywords

3D-MRE, 2D-MRE, HVPG

Brief summary

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.

Detailed 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.

Interventions

DEVICE3D-MRE

All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

DEVICEHVPG

HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures

DEVICE2D-MRE

All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis.12 monthsWIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE and 2D-MRE was compared.

Countries

China

Contacts

CONTACTYu Shi
18940259980@163.com
CONTACTZhiying Wang
wangzhiying990816@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026