3D-MRE and 2D-MRE for Assessing Cirrhosis and Portal Hypertension
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShengjing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age > 18 years old
confirmed cirrhosis (laboratory, imaging and clinical symptoms)
with 3D-MRE and 2D-MRE within 1 month prior to HVPG measurement
written informed consent
Disqualifiers
any previous liver or spleen surgery
liver cancer; chronic acute liver failure
acute portal hypertension
unreliable HVPG, 3D-MRE or 2D-MRE results due to technical reasons
Trial population
Organize paticipating units to collect standard-of-care data including radiological and clinical data. Patients diagnosed with cirrhosis who received HVPG measurement, 3D-MRE and 2D-MRE should be enrolled
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
3D-MRE
DeviceAll imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.
HVPG
DeviceHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
2D-MRE
DeviceAll imaging studies were performed by using a 3.0-T MRI system (Signa HDx, GE Healthcare) with an eight-channel phasedarray body coil.
HVPG
DeviceHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Experimental group2 interventions
Group B: Control group2 interventions
Trial outcomes
Primary outcomes
1
Accuracy of the features of 3D-MRE and 2D-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 and 2D-MRE was compared.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov