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4D-Flow MRI Assessment of Portal Hypertension and TIPS Outcomes in Cirrhosis
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-08-25
Completion Date
2028-05-01
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
4D-Flow Liver and heart MRI with Gadolinium injection
Non-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
Portal, hepatic and systemic veins blood collection
Locations (2)
Hôpital Pitié Salpêtrière
Paris, France
Service d'hépato-gastroentérologie
Paris, France