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Recruiting NCT02784119

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

No phase Interventional Liver Transplantation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: temporary porto-caval shunt.
Who it may be relevant to
Registry conditions: Liver Transplantation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure temporary porto-caval shunt
    temporary porto-caval shunt

Primary outcome measures

  • Incidence of early allograft dysfunction [Time frame: on postoperative day 7]
  • Incidence of early allograft dysfunction [Time frame: within the 7 first postoperative day]
  • Incidence of primary non function [Time frame: within the 7 first postoperative day]
Secondary outcome measures (8)
  • Realisation of intra-operative transfusion [Time frame: during the operation]
  • Incidence of reperfusion syndrome [Time frame: during the 5 minutes following revascularisation]
  • Duration of surgery [Time frame: at day 0]
  • Liver graft function [Time frame: within 3 months]
  • Occurrence of a severe postoperative complication [Time frame: within 3 months]
  • Evaluation of urinary function [Time frame: within the first 7 days]
  • Graft's survival [Time frame: at 3 months]
  • Patient's survival [Time frame: at 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

France · 6 centers
  • CHU Bordeaux — Bordeaux
  • Hospices Civils Lyon — Lyon
  • CHU Nice — Nice
  • CHU Rennes — Rennes
  • CHU Toulouse — Toulouse
  • CHU Tours — Tours

Identifiers

NCT: NCT02784119 · 2016-A00612-49 · 35RC15_8975

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗