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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-28

Study Completion Date

2025-07-31

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.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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temporary porto-caval shunt

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

Group Type EXPERIMENTAL

temporary porto-caval shunt

Intervention Type PROCEDURE

temporary porto-caval shunt

no temporary porto-caval shunt

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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temporary porto-caval shunt

Intervention Type PROCEDURE

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

* Fulminant hepatitis
* Retransplantation
* Combined organ transplantation (kidney, pancreas, heart, lung)
* Non heart beating donor
* Complete portal vein thrombosis on preoperative imaging finding