Informations générales (source: ClinicalTrials.gov)
APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor (APCext)
Interventional
N/A
Rennes University Hospital (Voir sur ClinicalTrials)
mars 2017
juillet 2025
24 septembre 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Rennes - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| CHU Tours - Tours - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Bordeaux - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| CHU Nice - Nice - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- Complete portal vein thrombosis found during procedure
- Split liver graft
- Realisation of a bilio-enteric anastomosis