Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT02784119

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

Led by Rennes University Hospital · Updated on 2024-09-23

214

Participants Needed

6

Research Sites

431 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Candidate for liver transplantation
  • Diagnosed with cirrhosis from any cause
  • Model For End-Stage Liver Disease (MELD) score less than 25
  • Receiving a liver graft from an extended criteria donor with at least one of the following: donor age over 65 years, intensive care unit stay longer than 7 days, body mass index over 30, sodium level above 155 mmol/L, aspartate aminotransferase (ASAT) over 150 IU/mL, alanine aminotransferase (ALAT) over 170 IU/mL, prior cardiac arrest before graft harvesting, or biopsy-proven liver fat over 30%
  • Patient does not object to participation
Not Eligible

You will not qualify if you...

  • Fulminant hepatitis
  • Previous liver retransplantation
  • Combined organ transplantation including kidney, pancreas, heart, or lung
  • Donor after cardiac death (non-heart beating donor)
  • Complete portal vein thrombosis seen on preoperative imaging
  • Complete portal vein thrombosis found during surgery
  • Split liver graft
  • Use of bilio-enteric anastomosis during surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 6 locations

1

CHU Bordeaux

Bordeaux, France

Actively Recruiting

2

Hospices Civils Lyon

Lyon, France

Actively Recruiting

3

CHU Nice

Nice, France

Actively Recruiting

4

CHU Rennes

Rennes, France

Actively Recruiting

5

CHU Toulouse

Toulouse, France

Actively Recruiting

6

CHU Tours

Tours, France

Actively Recruiting

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Research Team

M

Michel RAYAR, MD, PhD

CONTACT

A

Anne GANIVET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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