4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis

Trial statusNot yet recruiting
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

Qualifiers

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

Treatments tested in this trial

  • 4D-Flow Liver and heart MRI with Gadolinium injection
  • Samples Without DNA

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Sorbonne University

Collaborator

Institute of Cardiometabolism and Nutrition, France

Collaborator