Predicting Outcomes and Risk of Complications Related to Portal hyperTension by Non-invasive Assessment of Liver Flow With 4D MRI
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.
∙ Applicable to both groups :
• 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)
• Patient informed and written informed consent obtained
• Specific to the MASLD group :
• Indication for TIPS validated during a multidisciplinary team meeting and documented in the patient's medical record, including one of the following:
‣ Refractory ascites
⁃ Hepatic hydrothorax
⁃ Failure of secondary prophylaxis of variceal gastrointestinal bleeding
⁃ Preemptive TIPS
⁃ Preoperative TIPS
• Specific to the MASLD group :
• Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)
• Liver stiffness \> 15 kPa measured by transient elastography
• Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis
⁃ Alcohol consumption \< 20 g/day for women and \< 30 g/day for men, assessed using validated routine clinical questionnaires