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

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.

Study Overview

• Status: Recruiting
• Conditions: Portal Hypertension; Cirrhosis, Liver; Advanced Chronic Liver Disease
• Intervention / Treatment: Device: HVPG; Device: 3D-MRE

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Yifei Huang, M.D.; Phone Number: +86 158 0000 4518; Email: huangyf1995@foxmail.com
• Study Contact Backup: Name: Yu Shi, Prof.; Phone Number: +86 189 4025 9980; Email: 18940259980@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 210000
      • Recruiting
      • Shengjing Hospital
      • Contact: Yifei Huang, MD; Email: huangyf1995@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with cirrhosis who received HVPG measurement and 3D-MRE should be enrolled.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training cohort; Training cohort was set to develop the novel non-invasive model for virtual HVPG	Device: HVPG; HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.; Device: 3D-MRE; All imaging studies were performed by using a 3.0-T MRI system ( GE Healthcare) with a phasedarray body coil.
Validation cohort; Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments	Device: HVPG; HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.; Device: 3D-MRE; All imaging studies were performed by using a 3.0-T MRI system ( GE Healthcare) with a phasedarray body coil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the features of 3D-MRE for assessing portal hypertension in cirrhosis.	WIth HVPG as reference standand, the overall diagnostic perforemace (accuracy) for cirrhosis and portal hypertension of 3D-MRE was assessed.	12 months

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Collaborators: Zhongda Hospital
• Investigators: Principal Investigator: Yu Shi, Prof., Shengjing Hospital; Principal Investigator: Shenghong Ju, Prof., Zhongda Hospital; Principal Investigator: Xiaolong Qi, Prof., Zhongda Hospital

Publications and helpful links

General Publications

• Shi Y, Qi YF, Lan GY, Wu Q, Ma B, Zhang XY, Ji RY, Ma YJ, Hong Y. Three-dimensional MR Elastography Depicts Liver Inflammation, Fibrosis, and Portal Hypertension in Chronic Hepatitis B or C. Radiology. 2021 Oct;301(1):154-162. doi: 10.1148/radiol.2021202804. Epub 2021 Aug 10.
• Yu Q, Huang Y, Li X, Pavlides M, Liu D, Luo H, Ding H, An W, Liu F, Zuo C, Lu C, Tang T, Wang Y, Huang S, Liu C, Zheng T, Kang N, Liu C, Wang J, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Fang Q, Fu CC, Zhang R, Wang C, Wei J, Tian J, Ormeci N, Ellik Z, Asiller OO, Ju S, Qi X. An imaging-based artificial intelligence model for non-invasive grading of hepatic venous pressure gradient in cirrhotic portal hypertension. Cell Rep Med. 2022 Mar 15;3(3):100563. doi: 10.1016/j.xcrm.2022.100563. eCollection 2022 Mar 15.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: HVPG; 3D-MRE; advanced chronic liver disease
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: CHESS2206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No