3D-MRE for Assessing Cirrhosis, Advanced Chronic Liver Disease 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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
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 ( GE Healthcare) with a phasedarray body coil.
HVPG
DeviceHVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Training cohort2 interventions
Group B: Validation cohort2 interventions
Trial outcomes
Primary outcomes
1
Accuracy of the features of 3D-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 was assessed.
Time frame
12 monthsSponsors and contacts
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Shengjing Hospital
Lead sponsor
Zhongda Hospital
Collaborator
Source ClinicalTrials.gov