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

Rennes University Hospital

Status: Enrolling

Conditions: Liver Transplantation

Treatments: Procedure: temporary porto-caval shunt

Study type: Interventional

Funder types: Other

Identifiers

NCT02784119

2016-A00612-49

35RC15_8975 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

temporary porto-caval shunt

Experimental group

Description:

patients in whom temporary porto-caval shunt is performed during orthotopic liver transplantation

Treatment:

Procedure: temporary porto-caval shunt

no temporary porto-caval shunt

No Intervention group

Description:

patients in whom temporary porto-caval shunt is not performed during orthotopic liver transplantation