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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Transplantation

Intervention / Treatment
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* Procedure: temporary porto-caval shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Candidate of liver transplantation With cirrhosis from any etiology Model For End-Stage Liver Disease (MELD) score < 25 Transplanted with a liver graft harvested from an extended criteria donor defined as presence of at least one of the following criteria: Donor age > 65 years old Intensive care unit stay > 7 days BMI > 30 Natremia > 155 mmol/L Aspartate aminotransferase (ASAT) > 150 IU/mL Alanine aminotransferase (ALAT) > 170 IU/mL Occurrence of a cardiac arrest before graft harvesting Proven biopsy macrosteathosis > 30% Non-opposition from the patient Non Inclusion Criteria: Fulminant hepatitis Retransplantation Combined organ transplantation (kidney, pancreas, heart, lung) Non heart beating donor Complete portal vein thrombosis on preoperative imaging finding Exclusion Criteria: Complete portal vein thrombosis found during procedure Split liver graft Realisation of a bilio-enteric anastomosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: temporary porto-caval shunt<br>patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation | Procedure: temporary porto-caval shunt<br>* temporary porto-caval shunt<br>|
| No Intervention: no temporary porto-caval shunt<br>patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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 | 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 | 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 | within the 7 first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Realisation of intra-operative transfusion | defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool | during the operation | 
| Incidence of reperfusion syndrome | defined as decrease of 30% of the median arterial pressure | during the 5 minutes following revascularisation | 
| Duration of surgery |  | at day 0 | 
| Liver graft function | evaluated by the Model for Early Allograft Function (MEAF) score | within 3 months | 
| Occurrence of a severe postoperative complication | defined as a Clavien-Dindo classification > 2 | within 3 months | 
| Evaluation of urinary function | defined by: Measuring postoperative creatinine level (mg/L) Need of renal dialysis | within the first 7 days | 
| Graft's survival | defined by graft's death or retransplantation | at 3 months | 
| Patient's survival | defined by patient's death | at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporary porto-caval shunt, liver graft, extended criteria donor