Actively Recruiting
APCext : 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
431 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The success of orthotopic liver transplantation (OLT) in treatment of liver malignancy and endstage liver disease has led to an increase in the gap between patients on waiting-lists and available liver grafts. In order to compensate for this scarcity, use of liver grafts harvested from extended criteria donors (ECD) has become more and more frequent. However, these ECD grafts are known to be associated with a higher rate of primary non function (PNF) or early allograft dysfunction (EAD) because of a greater vulnerability to ischemia-reperfusion injury (IRI). During OLT, the clamping of the portal vein induces blood congestion in the splanchnic territory leading to increased gut permeability, bacterial translocation and release of endotoxin and pro-inflammatory cytokines at revascularisation, which exacerbate IRI. Realisation of a temporary porto-caval shunt (TPCS) (i.e. end to side anastomosis between the portal vein and infrahepatic vena cava) during the anhepatic phase, avoids splanchnic congestion and could therefore decrease IRI and improve liver graft function. However, TPCS remains poorly used as no randomised trial succeeds to show its benefit on liver function due to lack of power.
CONDITIONS
Official 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
- Diagnosed with 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 the following: donor age over 65 years, intensive care unit stay longer than 7 days, body mass index over 30, sodium level above 155 mmol/L, aspartate aminotransferase (ASAT) over 150 IU/mL, alanine aminotransferase (ALAT) over 170 IU/mL, prior cardiac arrest before graft harvesting, or biopsy-proven liver fat over 30%
- Patient does not object to participation
You will not qualify if you...
- Fulminant hepatitis
- Previous liver retransplantation
- Combined organ transplantation including kidney, pancreas, heart, or lung
- Donor after cardiac death (non-heart beating donor)
- Complete portal vein thrombosis seen on preoperative imaging
- Complete portal vein thrombosis found during surgery
- Split liver graft
- Use of bilio-enteric anastomosis during surgery
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Anne GANIVET
CONTACT
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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