Clinical trial NCT05475015: 3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease and Portal Hypertension
Official title: Three-dimensional MR Elastography for Assessing Cirrhosis and Portal Hypertension (CHESS2206): a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis, Liver
Portal Hypertension
Advanced Chronic Liver Disease
Keywords: 3D-MRE
HVPG
advanced chronic liver disease
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
First posted: 2022-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

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.

Eligibility criteria: Inclusion Criteria:

1. age \> 18 years old
2. confirmed cirrhosis or ACLD (advanced chronic liver disease) (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

Primary outcomes:
measure: Accuracy of the features of 3D-MRE for assessing portal hypertension in cirrhosis.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Yu Shi, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda Hospital
name: Shenghong Ju, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongda Hospital
name: Xiaolong Qi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.