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NCT Number: NCT02784119

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

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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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

temporary porto-caval shunt

Procedure

temporary porto-caval shunt

Primary outcomes

  1. Incidence of early allograft dysfunction

    Time frame: on postoperative day 7

    defined by the presence of at least one of the following criteria:

    • Bilirubin level > 10 mg/dL (i.e. 171 µmol/L)
    • International Normalized Ratio > 1.6

  2. Incidence of early allograft dysfunction

    Time frame: within the 7 first postoperative day

    defined by the presence of at least one of the following criteria:

    • ASAT or ALAT level > 2000 IU/mL

  3. Incidence of primary non function

    Time frame: within the 7 first postoperative day

    defined by the presence of at least one of the following criteria:

    • Graft's death or retransplantation
    • Patient's death

Secondary outcomes

  1. Realisation of intra-operative transfusion

    Time frame: during the operation

    defined by the transfusion needs of fresh frozen plasma, red blood cell and platelet pool

  2. Incidence of reperfusion syndrome

    Time frame: during the 5 minutes following revascularisation

    defined as decrease of 30% of the median arterial pressure

  3. Duration of surgery

    Time frame: at day 0

  4. Liver graft function

    Time frame: within 3 months

    evaluated by the Model for Early Allograft Function (MEAF) score

  5. Occurrence of a severe postoperative complication

    Time frame: within 3 months

    defined as a Clavien-Dindo classification > 2

  6. Evaluation of urinary function

    Time frame: within the first 7 days

    defined by:

    • Measuring postoperative creatinine level (mg/L)
    • Need of renal dialysis

  7. Graft's survival

    Time frame: at 3 months

    defined by graft's death or retransplantation

  8. Patient's survival

    Time frame: at 3 months

    defined by patient's death

Study contacts

Contact information is provided by the study sponsor or research team.

Anne GANIVET

CONTACT

[email protected]

02 99 28 25 55

Michel RAYAR, MD, PhD

CONTACT

[email protected]

02 99 28 42 65

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: APCext

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
May 26, 2016
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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