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RecruitingNCT05475015

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

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Shengjing Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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 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.

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 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

Interventions

TypeNameDescription
DEVICE3D-MREAll imaging studies were performed by using a 3.0-T MRI system ( GE Healthcare) with a phasedarray body coil.
DEVICEHVPGHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.

Timeline

Start date
2022-08-16
Primary completion
2026-07-01
Completion
2026-12-01
First posted
2022-07-26
Last updated
2026-02-09

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05475015. Inclusion in this directory is not an endorsement.