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Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
Led by Rennes University Hospital · Updated on 2024-09-23
214
Participants Needed
6
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying liver transplantation in patients with liver cancer or end-stage liver disease who receive grafts from extended criteria donors (ECD). These donors have factors that increase the risk of complications like primary non-function or early graft dysfunction due to greater susceptibility to injury during transplantation. The study aims to evaluate whether using a temporary porto-caval shunt (TPCS) during the transplant surgery can reduce these risks by preventing blood congestion and inflammation in the gut. Participants are randomly assigned to one of two groups: those who receive the temporary porto-caval shunt during the transplant surgery and those who do not. The shunt is created by connecting the portal vein to the vena cava during the phase when the liver is removed. This procedure is intended to reduce damage during the operation. The study measures outcomes such as early graft function and complications within the first week after surgery. During the study, researchers will monitor liver function and complications up to three months after transplantation. They will assess early allograft dysfunction and primary non-function within the first seven postoperative days, along with surgery duration, transfusions, reperfusion syndrome shortly after blood flow restoration, urinary function, and survival of both graft and patient. Participants will be followed closely during this time to evaluate the effects of the shunt on transplant outcomes.
CONDITIONS
Brief Title
APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Candidate for liver transplantation
- Presence of cirrhosis from any cause
- Model For End-Stage Liver Disease (MELD) score less than 25
- Receiving a liver graft from an extended criteria donor with at least one of these: donor age over 65, intensive care unit stay over 7 days, BMI over 30, high natremia, high liver enzymes, cardiac arrest before graft harvesting, or biopsy showing over 30% fat
- Patient does not oppose participation
You will not qualify if you...
- Fulminant hepatitis
- Retransplantation
- Combined organ transplantation (kidney, pancreas, heart, lung)
- Non-heart beating donor
- Complete portal vein thrombosis on imaging before surgery
- Complete portal vein thrombosis found during surgery
- Split liver graft
- Performance of a bilio-enteric anastomosis during surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0 and immediate post-operative period
Participants undergo orthotopic liver transplantation with or without a temporary porto-caval shunt during surgery, followed by immediate post-operative monitoring.
1 surgery visit and immediate post-operative monitoring
Duration - Up to 3 months
Participants are monitored for liver graft function, complications, and survival for up to 3 months after surgery.
Regular follow-up visits within the first 7 days and additional visits up to 3 months
Trial Site Locations
Total: 6 locations
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
2
Hospices Civils Lyon
Lyon, France
Actively Recruiting
3
CHU Nice
Nice, France
Actively Recruiting
4
CHU Rennes
Rennes, France
Actively Recruiting
5
CHU Toulouse
Toulouse, France
Actively Recruiting
6
CHU Tours
Tours, France
Actively Recruiting
Research Team
M
Michel RAYAR, MD, PhD
A
Anne GANIVET
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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