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

  • STATUS
    Recruiting
  • End date
    Jul 14, 2024
  • participants needed
    214
  • sponsor
    Rennes University Hospital
Updated on 14 May 2022
cancer
cytokines
hepatitis
organ transplantation
congestion
cardiac arrest
liver disease
cirrhosis
reperfusion injury
orthotopic liver transplant

Summary

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.

Details
Condition Liver Transplantation
Treatment temporary porto-caval shunt
Clinical Study IdentifierNCT02784119
SponsorRennes University Hospital
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

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
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