AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
💬

In plain words

What the trial is, and whether it could suit you

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 cirr

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

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

Where

2 sites
Hôpital Pitié Salpêtrière
Paris, France
Service d'hépato-gastroentérologie
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy