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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
214
temporary porto-caval shunt
CHU Bordeaux
Bordeaux, France
RECRUITINGHospices Civils Lyon
Lyon, France
RECRUITINGCHU Nice
Nice, France
RECRUITINGCHU Rennes
Rennes, France
RECRUITINGCHU Toulouse
Toulouse, France
RECRUITINGCHU Tours
Tours, France
RECRUITINGIncidence of early allograft dysfunction
defined by the presence of at least one of the following criteria: * Bilirubin level \> 10 mg/dL (i.e. 171 µmol/L) * International Normalized Ratio \> 1.6
Time frame: on postoperative day 7
Incidence of early allograft dysfunction
defined by the presence of at least one of the following criteria: • ASAT or ALAT level \> 2000 IU/mL
Time frame: within the 7 first postoperative day
Incidence of primary non function
defined by the presence of at least one of the following criteria: * Graft's death or retransplantation * Patient's death
Time frame: within the 7 first postoperative day
Realisation of intra-operative transfusion
defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool
Time frame: during the operation
Incidence of reperfusion syndrome
defined as decrease of 30% of the median arterial pressure
Time frame: during the 5 minutes following revascularisation
Duration of surgery
Time frame: at day 0
Liver graft function
evaluated by the Model for Early Allograft Function (MEAF) score
Time frame: within 3 months
Occurrence of a severe postoperative complication
defined as a Clavien-Dindo classification \> 2
Time frame: within 3 months
Evaluation of urinary function
defined by: * Measuring postoperative creatinine level (mg/L) * Need of renal dialysis
Time frame: within the first 7 days
Graft's survival
defined by graft's death or retransplantation
Time frame: at 3 months
Patient's survival
defined by patient's death
Time frame: at 3 months
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