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3D-MRE for Assessing Cirrhosis and Portal Hypertension

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ClinicalTrials.gov Identifier: NCT05475015
Recruitment Status : Not yet recruiting
First Posted : July 26, 2022
Last Update Posted : July 29, 2022
Sponsor:
Collaborator:
Zhongda Hospital
Information provided by (Responsible Party):
Yu Shi, 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 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
Cirrhosis, Liver Portal Hypertension 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Accuracy of the features of 3D-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 was assessed.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05475015


Contacts
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Contact: Yifei Huang, M.D. huangyf1995@foxmail.com

Sponsors and Collaborators
Shengjing Hospital
Zhongda Hospital
Investigators
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Principal Investigator: Yu Shi, Prof. Shengjing Hospital
Principal Investigator: Shenghong Ju, Prof. Zhongda Hospital
Principal Investigator: Xiaolong Qi, Prof. Zhongda Hospital
Publications:
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Responsible Party: Yu Shi, Deputy director of department of radology, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT05475015    
Other Study ID Numbers: CHESS2206
First Posted: July 26, 2022    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu Shi, Shengjing Hospital:
3D-MRE
HVPG
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases