RecruitingNAINTERVENTIONAL

APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor

Liver transplants are life-saving, but there aren't enough perfect livers for everyone. So, doctors sometimes use livers from 'extended criteria donors,' which might be older or have other factors that make them a bit riskier. These livers can be more prone to damage when blood flow returns after being without it during surgery. This study is testing a technique called a temporary porto-caval shunt (TPCS). This involves briefly rerouting blood around the liver during the transplant to prevent a build-up of pressure in the gut. The goal is to see if this helps protect the new liver from damage when blood flow restarts, leading to a better outcome for the patient. Previous studies haven't been large enough to definitively prove its benefits, so this research aims to provide clearer answers.

At a glance

Status

Recruiting

Phase

Sponsor

Rennes University Hospital

Enrolment target

214

Start

28 Mar 2017

Estimated completion

01 Jul 2025

Liver Transplantation

What is this study about?

If you or someone you know is facing a liver transplant, you're likely aware of how crucial these operations are. Unfortunately, there's a shortage of 'perfect' donor livers, meaning that doctors sometimes have to use livers from donors who might be older or have other health conditions. While these livers are still good and help more people get transplants, they can be a bit more fragile and more susceptible to damage during the surgery itself.

This study focuses on a specific part of the liver transplant operation. During the transplant, there's a period when the main blood vessel to the liver is clamped. This can cause blood to build up in the digestive system, which releases substances that can harm the new liver when blood flow is restored. This damage is a known problem and can affect how well the new liver works in the first few days or weeks after the transplant.

The research is investigating whether a temporary procedure, called a 'porto-caval shunt' (TPCS), can help prevent this problem. A TPCS is like a temporary bypass pipe that reroutes blood around the liver during the surgery. The idea is that by preventing this blood build-up, we can protect the new liver, especially those that are a bit more vulnerable, and potentially help them function better and last longer after the transplant. This study hopes to provide clear answers on whether this technique is truly beneficial.

Key takeaways

This study evaluates a temporary surgical technique during liver transplants.
It aims to protect new livers, especially those from 'extended criteria donors'.
The goal is to improve how well the new liver works after transplant.
No extra appointments or medications are required beyond standard care.
Participation is voluntary and will not affect your medical treatment.

Who may be eligible?

This study is looking for adults aged 18 or older who are having a liver transplant for long-term liver disease. You would be considered if your new liver comes from an 'extended criteria donor.' This means the donor liver might have some characteristics that make it a bit riskier, such as coming from an older donor (over 65), a donor who was in intensive care for a longer time, or had a higher BMI or certain blood test results.

There are also some reasons why you wouldn't be able to join the study. For example, if you have very sudden, severe liver failure (fulminant hepatitis), if this is a repeat transplant, or if you're having other organs transplanted at the same time (like a kidney or pancreas). Also, if you have a complete blockage of the main vein to the liver before the operation, or if the donor liver is a 'split liver' (meaning it's only a part of a liver) or from a donor whose heart had already stopped before organ retrieval, you wouldn't be eligible.

Finally, if during the operation, a complete blockage of the main liver vein is discovered, or if a specific type of connection between the liver and bowel is made, you wouldn't be able to stay in the study even if you initially joined. The research team will discuss all these points with you carefully.

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.

Are you 18 years old or older?
Are you scheduled for a liver transplant due to long-term liver disease?
Is your donor liver likely to be from an 'extended criteria donor' (e.g., older donor, higher BMI, etc.)?
Are you NOT having a second transplant, a combined organ transplant, or for sudden severe liver failure?
Are you happy for your medical information to be used anonymously for research?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main intervention involves the surgical team performing a temporary porto-caval shunt during your liver transplant operation. This is done while you are under general anaesthetic as part of the normal surgical process. After your transplant, you will receive standard medical care and monitoring, just like any other transplant patient. The study primarily involves the surgical technique and then observing how your new liver functions and how you recover. There won't be any extra visits or follow-up appointments solely for the study beyond what your transplant team would normally arrange. Your medical team will continue to monitor your health and the function of your new liver as part of your ongoing care.

Potential risks and benefits

Taking part in this study means that a specific surgical technique will be used during your liver transplant. While this technique aims to protect your new liver and improve its function, like any medical procedure, there are always potential, though rare, risks associated with it, which your surgeon will discuss in detail. The potential benefit is that the temporary shunt could help reduce damage to your new liver, especially if it's from an 'extended criteria donor,' potentially leading to a smoother recovery and better long-term liver function. You are free to withdraw from the study at any time without affecting your medical care. Your decision to participate or not will not impact the quality of care you receive.

Locations (6)

CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Hospices Civils Lyon
Verified postcode
Lyon, France· Recruiting
CHU Nice
Verified postcode
Nice, France· Recruiting
CHU Rennes
Verified postcode
Rennes, France· Recruiting
CHU Toulouse
Verified postcode
Toulouse, France· Recruiting
CHU Tours
Verified postcode
Tours, France· Recruiting

Common questions

What is an 'extended criteria donor' liver?

These are donor livers that might be a bit older, from donors who had specific health conditions, or other factors that make the liver slightly more fragile, but still perfectly suitable for transplant.

What is a temporary porto-caval shunt?

It's a temporary bypass procedure performed during the liver transplant operation to briefly reroute blood flow, aiming to protect the new liver from potential damage.

Will taking part in this study change my transplant surgery a lot?

The main change is a specific technique used during the operation itself, which is performed by the surgical team while you are under anaesthetic. Your overall transplant experience and recovery will largely follow standard procedures.

Are there extra appointments if I join this study?

No, there are no extra appointments specifically for this study. Your medical team will monitor your recovery and new liver function as part of your usual post-transplant care.

Can I change my mind after joining the study?

Yes, you are completely free to withdraw from the study at any time, for any reason, without affecting your medical care or treatment.

How to find out more

Michel RAYAR, MD, PhD

michel.rayar@chu-rennes.fr 02 99 28 42 65 Official trial record

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