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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05475015
Enrollment
150
Registered
2022-07-26
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, Advanced Chronic Liver Disease

Keywords

3D-MRE, HVPG, advanced chronic liver disease

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 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.

Interventions

DEVICE3D-MRE

All imaging studies were performed by using a 3.0-T MRI system ( GE Healthcare) with a phasedarray body coil.

DEVICEHVPG

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

Sponsors

Shengjing Hospital
Lead SponsorOTHER
Zhongda Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

were: (1) ≥18 years; (2) written informed consent; (3) confirmed ACLD of any liver disease etiology; (4) clinically indicated for HVPG measurement, with 3D-MRE performed within one month prior.

Exclusion criteria

were: (1) hepatic or extrahepatic malignancies, or large hepatic or splenic focal diseases affecting MRE measurement; (2) MR or HVPG contraindications; (3) prior liver or splenic surgery affecting MRE measurement; (4) treatment with nonselective β-blockers (NSBB) between MRE and HVPG measurements; (5) invalid or unreliable HVPG or MRE results and (6) biliary obstruction or dilation on MR images.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the features of 3D-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 was assessed.

Countries

China

Contacts

CONTACTYifei Huang, M.D.
huangyf1995@foxmail.com+86 158 0000 4518
CONTACTYu Shi, Prof.
18940259980@163.com+86 189 4025 9980
PRINCIPAL_INVESTIGATORYu Shi, Prof.

Shengjing Hospital

PRINCIPAL_INVESTIGATORShenghong Ju, Prof.

Zhongda Hospital

PRINCIPAL_INVESTIGATORXiaolong Qi, Prof.

Zhongda Hospital

Outcome results

None listed

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