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Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

This study is exploring a new, small, and quick-to-use device called a spectrometer. Its purpose is to check donor livers for fatty changes, known as steatosis, right there in the operating room. Fatty livers can sometimes be less suitable for transplant. The researchers want to see if this pocket-sized tool can reliably and accurately measure fat in donor livers before they are transplanted. Surgeons will use the device on a small part of the liver before the transplant begins, but they won't know the device's results at the time. This information will be compared later with standard lab tests to see how well the new device works. The ultimate goal is to make liver transplants safer and more successful by quickly identifying optimal donor livers.

At a glance

Status
Recruiting
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrolment target
240
Start
14 Jan 2022
Estimated completion
14 Nov 2024
Liver Transplants

What is this study about?

When someone needs a liver transplant, finding a suitable donor liver is crucial. Sometimes, donor livers can have too much fat, a condition called steatosis. While some fat is okay, a liver with a lot of fat might not work as well after transplant, or in some cases, might not be suitable for transplant at all. Currently, doctors often rely on looking at the liver or taking a small sample (a biopsy) for lab tests, but these methods can take time or might not be perfectly consistent.

This study is looking into a brand-new way to check for fat in donor livers using a special device called a spectrometer. Imagine a small, handheld tool that can quickly scan the liver during the transplant operation. The aim is for this device to be speedy, reliable, and able to give clear information about the amount of fat in the liver, helping surgeons make the best decisions for patients.

The researchers hope that this new tool will make the process of evaluating donor livers more efficient and accurate. By quickly identifying livers with too much fat, it could help ensure that only the healthiest livers are transplanted, potentially leading to better results for people receiving a new liver.

Key takeaways

  • Researchers are testing a new small device to check donor livers for fat.
  • The device aims to quickly and accurately measure fat in the liver during transplant operations.
  • This could help surgeons choose the best donor livers for transplant patients.
  • The study compares the new device's readings with standard lab tests.
  • It could make liver transplants safer and more successful in the future.

Who may be eligible?

This study is looking for information from donor livers that come from people who have sadly died and donated their organs (often called 'brain-dead' donors). Donors must be 18 years old or older. It's also important that the donor and their family have already agreed for their health information to be used for research purposes.

There are some reasons why a donor liver might not be included. For instance, livers from living donors are not part of this study. Also, if a donor had a severe liver injury or certain past surgeries that would make it difficult to use the special scanning device, their liver wouldn't be included. If a donor had certain conditions like a history of chemotherapy or very high levels of some liver-related substances in their blood, their liver might also not be suitable for the study.

The research specifically excludes livers that appear to have significant scarring or stiffness, which typically means they are already quite unhealthy. The aim is to test the device on livers that are generally considered for transplant but where the amount of fat might be a question mark.

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. The donor was 18 years old or older.
  2. The donor was 'brain-dead' (not a living donor).
  3. The donor and family agreed to research use of medical information.
  4. The donor liver didn't show signs of pre-existing severe scarring.
  5. The donor didn't have certain complex abdominal surgeries in the past.
  6. The donor didn't have high levels of certain substances in their blood related to liver issues.
Answer every question to see your result.

What does participation involve?

This study involves gathering information during a standard liver transplant operation. If a donor liver meets the study's requirements, the surgeon will use the special scanning device (spectrometer) on five different spots on a part of the liver (the left lobe) before the main transplant procedure begins. This is done while the liver is still connected and before certain blood vessels are clamped. The surgeon will not be told what the scanner finds at that moment. After the scan, the surgeon may also take a small tissue sample (a biopsy) as part of their usual practice. The information from the scanning device will then be compared later with the results from the standard lab tests on the biopsy sample. This is not a study where you, as a patient receiving a liver, would be directly involved or need extra visits. The focus is on evaluating the donor liver itself.

Potential risks and benefits

There are no direct risks or benefits to the patient receiving the liver, as this study focuses on the donor organ and the transplant procedure itself. The use of the spectrometer on the donor liver is a quick procedure and does not interfere with the transplant process. The aim is to improve the assessment of donor livers in the future, which could lead to better outcomes for all patients needing a liver transplant. If a donor family has given consent for research, their data will be used. They always have the right to withdraw their consent for research data use at any time without affecting the care of the recipient.

Locations (3)

  • Centre Hépato Biliaire de l'hopital Paul Brousse
    Verified postcode
    Villejuif, France· Recruiting
  • Hôpital Beaujon
    Verified postcode
    Clichy, France· Recruiting
  • Hôpital Pitié-Salpetriere
    Verified postcode
    Paris, France· Recruiting

Common questions

What is 'steatosis'?

Steatosis means there is too much fat in the liver. It's sometimes called 'fatty liver'.

What is a 'spectrometer'?

A spectrometer is a device that can analyze light to tell us things about what it's looking at, in this case, the amount of fat in a liver tissue.

Will this experiment affect the quality of the donated liver?

No, the scan is very brief and minimally invasive. It's designed not to harm the donor liver or affect the transplant process.

Who is paying for this research?

The information provided does not specify the funding source for this clinical trial.

How long will the study take?

The study's duration isn't specified, but it involves collecting data as donor livers become available during transplant operations.

How to find out more

Official trial record

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 "Estimation of Steatosis on Liver Transplants by Intraoperati…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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