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NCT Number: NCT06205992

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location status: Recruiting

Location contact

Yu Shi, MD

CONTACT

[email protected]

+8618940259980

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

3D-MRE

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

Device

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

2D-MRE

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.

Primary outcomes

  1. Accuracy of the features of 3D-MRE and 2D-MRE for assessing portal hypertension in cirrhosis.

    Time frame: 12 months

    WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE and 2D-MRE was compared.

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Shi

CONTACT

[email protected]

Zhiying Wang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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