3D-MRE for Assessing Cirrhosis and Portal Hypertension

Sponsor
Shengjing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05475015
Collaborator
Zhongda Hospital (Other)
100
28

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: 3D-MRE
  • Device: HVPG

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.

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Three-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension (CHESS2206): A Prospective Multicenter Study
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Training cohort

Training cohort was set to develop the novel non-invasive model for virtual HVPG

Device: 3D-MRE
All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

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

Validation cohort

Validation cohort was set to validate the novel non-invasive model for virtual HVPG in different people in same environments

Device: 3D-MRE
All imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.

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

Outcome Measures

Primary Outcome Measures

  1. Accuracy of the features of 3D-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 was assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. age > 18 years old

  2. confirmed cirrhosis (laboratory, imaging and clinical symptoms)

  3. with 3D-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 or 3D-MRE results due to technical reasons

  5. with liver interventional therapy between HVPG and 3D-MRE

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shengjing Hospital
  • Zhongda Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yu Shi, Deputy director of department of radology, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT05475015
Other Study ID Numbers:
  • CHESS2206
First Posted:
Jul 26, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yu Shi, Deputy director of department of radology, Shengjing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022