4D-Flow MRI to see portal hypertension and TIPS outcomes in cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PORTAL-4D is a prospective, interventional, non-randomized study at a Paris hospital that uses 4D-flow MRI to measure hepatic and portal hemodynamics as a potential noninvasive alternative to HVPG. Participants are adults with cirrhosis, split into two groups: compensated MASLD-related cirrhosis and decompensated cirrhosis referred for TIPS. The study aims to correlate 4D-flow MRI metrics with portal hypertension and post-procedural outcomes, while addressing the invasiveness and limited availability of HVPG. Imaging is performed with gadolinium contrast, and results may guide clinical decisions without invasive pressure measurements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Applicable to both groups :

1. Age ≥ 18 years
2. Eligible to undergo MRI examination
3. Prior clinical evaluation completed
4. Covered by a national health insurance scheme or beneficiary thereof (excluding State Medical Aid AME)
5. Patient informed and written informed consent obtained

   Specific to the MASLD group :
6. 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 :
7. Past or current exposure to metabolic risk factors (overweight, obesity, type 2 diabetes mellitus, arterial hypertension, dyslipidemia)
8. Liver stiffness \> 15 kPa measured by transient elastography
9. Liver biopsy documenting steatosis with stage 3 fibrosis or cirrhosis
10. Alcohol consumption \< 20 g/day for women and \< 30 g/day for men, assessed using validated routine clinical questionnaires

Exclusion Criteria:

Applicable to both groups :

1. Any contraindication to MRI (cardiac pacemaker, implantable cardioverter-defibrillator, cochlear implants, intraocular metallic foreign bodies, intracranial vascular clips).
2. Prior liver transplantation.
3. Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception.
4. Individual under legal guardianship or trusteeship, or unable to provide informed consent.
5. Participation in another interventional clinical study or currently within the exclusion period following a previous ongoing study.

   Specific to the TIPS group
6. Patients undergoing salvage TIPS placement in the setting of hemorrhagic shock. Specific to the MASLD group
7. Other etiologies of chronic liver disease, including viral hepatitis, autoimmune liver disease, or hemochromatosis

Where it's running

• Hôpital Pitié Salpêtrière
  Paris, France Recruiting
• Service d'hépato-gastroentérologie
  Paris, France Recruiting

Study contacts

• Principal investigator: Louis MEYBLUM, MD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Louis MEYBLUM, MD
• Email: louis.meyblum@aphp.fr
• Phone: +331 84 82 82 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.