3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease and Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-16

Study Completion Date

2025-12-01

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 or advanced chronic liver disease. 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 or advanced chronic liver disease.

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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 and advanced chronic liver disease.

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 and advanced chronic liver disease.

Conditions

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Cirrhosis, Liver Portal Hypertension Advanced Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Training cohort

Training cohort was set to develop the novel non-invasive model for virtual HVPG

3D-MRE

Intervention Type DEVICE

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

HVPG

Intervention Type DEVICE

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

Validation cohort

Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments

3D-MRE

Intervention Type DEVICE

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

HVPG

Intervention Type DEVICE

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

Interventions

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3D-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.

Intervention Type DEVICE

HVPG

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. age \> 18 years old
2. confirmed cirrhosis or ACLD (advanced chronic liver disease) (laboratory, imaging and clinical symptoms)
3. with 3D-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 or 3D-MRE results due to technical reasons
5. with liver interventional therapy between HVPG and 3D-MRE

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No