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Not yet recruitingNAINTERVENTIONAL

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

This study, called PORTAL-4D, is looking for a less invasive way to assess liver pressure (portal hypertension) in people with cirrhosis. Currently, this involves an internal measurement that requires a specialist. The study will use a new type of MRI scan, called 4D-Flow MRI, to see if it can accurately measure this pressure from outside the body. Researchers will compare the new MRI scan results with the current internal measurement. They also want to see if the MRI can predict who will get complications or how well people do after a specific procedure called TIPS. The ultimate goal is to find a safer, easier way to check on liver health and guide treatment decisions.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
60
Start
01 Jun 2026
Estimated completion
01 May 2028

What is this study about?

Imagine your liver has scars (cirrhosis), which can make it harder for blood to flow through it. This can cause pressure to build up in the blood vessels leading to your liver, a condition called portal hypertension. This high pressure can lead to serious problems like fluid build-up in the tummy, bleeding, and confusion.

Currently, to measure this pressure accurately, doctors need to perform an internal procedure where a thin tube is guided into a vein to measure the pressure directly. This is quite involved and needs specially trained doctors. Because of this, it's not available everywhere, and it can be uncomfortable for patients. That's why doctors are really keen to find a different, easier way to get this information.

This study is testing a special type of MRI scan called a 4D-Flow MRI. This advanced scan can take detailed pictures of blood flow in and around the liver without needing any internal tubes. The researchers want to see if the information from this MRIscan matches the measurements from the current internal procedure. They also hope to find out if this MRI can help predict who might get complications from liver disease or how well people will recover after a procedure called a TIPS (Transjugular Intrahepatic Portosystemic Shunt), which helps relieve the pressure in the liver. If successful, this new MRI could become a valuable, non-invasive tool to help doctors better manage liver disease.

Key takeaways

  • This study uses a special MRI to measure liver pressure (portal hypertension).
  • It aims to find a non-invasive alternative to a current internal procedure.
  • Participation involves an MRI scan with a contrast injection and providing samples.
  • The study helps improve future diagnosis and management of liver conditions.
  • There are two groups: one with early cirrhosis and one awaiting a TIPS procedure.
  • Your health will be monitored for 6 months after the MRI scan.

Who may be eligible?

To be considered for this study, you must be 18 years or older and able to have an MRI scan. You'll also need to have had a recent check-up for your liver condition and be covered by national health insurance.

The study is looking for two groups of people: One group will have compensated cirrhosis related to fatty liver disease (MASLD). The other group will have more advanced cirrhosis and are scheduled for a TIPS procedure.

There are also some reasons why you might not be able to join. For example, if you have certain medical devices that are not MRI-safe, if you've had a liver transplant, are pregnant or breastfeeding, or if you're taking part in another clinical study right now, you won't be able to participate. If you're having a TIPS procedure as an emergency measure for severe bleeding, you also wouldn't be able to join the TIPS group.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Can you safely have an MRI scan?
  3. Do you have cirrhosis?
  4. Are you covered by national health insurance?
  5. Are you *not* pregnant, breastfeeding, or planning to get pregnant without effective contraception?
  6. Are you *not* participating in another medical study right now?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you will have a special MRI scan of your liver and heart. This will involve an injection of a special dye (called Gadolinium) to help the images appear clearer. You will also provide some samples, though these will not be used for DNA testing. The study does not involve new medications, but rather focuses on a new diagnostic test. Researchers will also be looking at your health over the following six months to see how you are doing. The exact number of visits will be discussed, but it will involve at least one MRI scan and follow-up checks.

Potential risks and benefits

The main benefit of taking part is that you would be contributing to research that could lead to a simpler, less invasive way for people with liver conditions to be diagnosed and monitored, which could help many patients in the future. There are always some risks with MRI scans, such as reactions to the contrast dye, though these are usually mild. You will be monitored closely during your scan. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Hôpital Pitié Salpêtrière
    Verified postcode
    Paris, France

Common questions

What is portal hypertension?

It's when there's high blood pressure in the veins leading to your liver, often caused by liver scarring (cirrhosis).

What is an MRI scan?

It's a type of scan that uses strong magnets and radio waves to create detailed images of organs and structures inside your body.

What is a TIPS procedure?

It's a treatment that involves placing a small tube in the liver to create a new path for blood flow, which helps reduce high pressure in the liver.

Will I have to pay to participate?

No, you should not incur costs for participating in the study if you are covered by national health insurance.

How long will the study last for me?

Your involvement in the study will include an MRI scan and follow-up checks for about six months.

How to find out more

Louis MEYBLUM, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "4D-Flow MRI Assessment of Portal Hypertension and TIPS Outco…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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