4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
PORTAL-4D is a prospective, interventional, non-randomized, parallel-group diagnostic study conducted at Pitié-Salpêtrière Hospital (Paris, France).
Portal hypertension is the main driver of hepatic decompensation and is associated with ascites, variceal bleeding, hepatic encephalopathy, and reduced survival. The current gold standard for assessing portal hypertension is the invasive hepatic venous pressure gradient (HVPG) measurement performed via the transjugular route. However, HVPG is invasive, operator-dependent, and limited to specialized centers. A reliable non-invasive alternative is therefore highly needed.
60 adults patients with cirrhosis will be enrolled and divided into two parallel groups: MASLD group (n=24): Patients with compensated cirrhosis related to metabolic dysfunction-associated steatotic liver disease (MASLD).
TIPS group (n=36): Patients with decompensated cirrhosis referred for transjugular intrahepatic portosystemic shunt (TIPS) placement.
The primary objective is to assess the correlation between invasive HVPG values and 4D-flow MRI parameters. Secondary objectives include evaluating the prognostic value of 4D-flow MRI in predicting portal hypertension-related complications and post-TIPS outcomes within 6 months.
The study is expected to validate 4D-flow MRI as an non-invasive diagnostic and prognostic tool for portal hypertension, potentially improving patient selection for TIPS and reducing reliance on invasive procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Eligible to undergo MRI examination
Prior clinical evaluation completed
Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)
Disqualifiers
Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).
Prior liver transplantation.
Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.
Individual under legal guardianship or trusteeship, or unable to provide informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
4D-Flow Liver and heart MRI with Gadolinium injection
Other interventionNon-invasive hepatic 4D-flow magnetic resonance imaging performed with gadolinium contrast to quantify portal and systemic venous blood flow, velocities, and shunt fraction. Measurements are compared with invasive hepatic venous pressure gradient (HVPG) values and clinical outcomes to assess diagnostic accuracy and prognostic value for portal hypertension-related complications.
Samples Without DNA
Biological/VaccinePortal, hepatic and systemic veins blood collection
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: TIPS groupExperimental treatment 2 interventions
Group B: MASLD groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Correlation between invasive hepatic venous pressure gradient (HVPG) and quantitative hepatic 4D-flow MRI hemodynamic parameters
The primary outcome is the association between the invasive hepatic venous pressure gradient (HVPG; wedged hepatic venous pressure minus free hepatic venous pressure) measured during transjugular catheterization and quantitative hepatic 4D-flow MRI-derived parameters, including flow rate and peak velocity in the portal venous system (main portal vein and right/left branches), splenic vein, superior mesenteric vein, hepatic veins, and inferior vena cava. When available, direct portal pressure will be recorded as supportive invasive data
Time frame
Baseline (4D-flow MRI performed within 3 days before or after invasive measurements)Secondary outcomes
1
: Correlation between 4D Flow MRI measured flows and the percentage of shunt with the incidence of events related to portal hypertension
Evaluation of the correlation between 4D Flow MRI-measured flows and the percentage of shunt (ratio of splenomesenteric inflow to hepatic venous outflow). Incidence of events related to portal hypertension, including: * Ascites requiring diagnostic or therapeutic paracentesis. * Hospitalization for encephalopathy. * Variceal rupture. * Liver-related death in patients without prior decompensation. Method of Measurement: 4D Flow MRI to assess the flow rates and calculate the shunt percentage (ratio of splenomesenteric inflow to hepatic venous outflow). Clinical event documentation (hospitalization, paracentesis, etc.) in the 6-month follow-up period.
Time frame
6 months2
Correlation between proteomic signatures and the occurrence of hepatic encephalopathy
Evaluation of the correlation between proteomic signatures (measured using mass spectrometry) and the onset of hepatic encephalopathy in patients with compensated cirrhosis. Method of Measurement: Mass spectrometry for proteomic analysis. Unit of Measure: Protein concentration (mg/mL).
Time frame
Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure3
Correlation between transcriptomic signatures and the occurrence of hepatic encephalopathy
Evaluation of the correlation between transcriptomic signatures (measured by RNA sequencing) and the onset of hepatic encephalopathy in patients with compensated cirrhosis. Method of Measurement: RNA sequencing for transcriptomic profiling. Unit of Measure: Gene expression levels (RPKM or TPM).
Time frame
Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedure4
Correlation between metabolomic signatures and the occurrence of hepatic encephalopathy.
Evaluation of the correlation between metabolomic profiles (measured by mass spectrometry or NMR) and the occurrence of hepatic encephalopathy in patients with compensated cirrhosis. Method of Measurement: Mass spectrometry or NMR for metabolite profiling. Unit of Measure: Metabolite concentration (µM, nmol/mL).
Time frame
Occurrence of hepatic encephalopathy will be monitored for 6 months following the TIPS procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Sorbonne University
Collaborator
Institute of Cardiometabolism and Nutrition, France
Collaborator
Source ClinicalTrials.gov