Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205992
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2024-01-04
Brief Title:
3D-MRE and 2D-MRE for Assessing Cirrhosis and Portal Hypertension
Sponsor:
Shengjing Hospital
Organization:
Shengjing Hospital
Study Overview
Official Title:
Three-dimensional MR Elastography and Two-dimensional MR Elastography for Assessing Cirrhosis and Portal HypertensionA Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10121620 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None