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

Recruiting

• Conditions: Cirrhosis; Liver Portal Hypertension
• Interventions: Device: 2D-MRE; Device: 3D-MRE; Device: HVPG

• Registration Number: NCT06205992
• Lead Sponsor: Shengjing Hospital

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. 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 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.

Study Timeline

• Study Start: 2022-08-16
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	2D-MRE	Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE
Control group	HVPG	Control group was set to develop the novel non-invasive model for virtual HVPG using 2d-MRE
Experimental group	3D-MRE	Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE
Experimental group	HVPG	Experimental group was set to develop the novel non-invasive model for virtual HVPG using 3d-MRE

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China