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

Study acronym: APCext
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 23, 2024 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary completion date: Jul 2024 to Jul 2025
    • Study sites: 5 to 6
    v9
  3. Notable Primary completion date: Jul 2023 to Jul 2024
    • Study completion date: Jul 2024 to Jul 2025
    v8
  4. Minor Re-verified, no change to tracked fieldsv7
  5. Notable Primary completion date: Jul 2021 to Jul 2023
    • Study completion date: Jul 2022 to Jul 2024
    • Site details revised at 1 of 5 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Study sites: 4 to 5
    • Primary completion date: Mar 2021 to Jul 2021
    • Study completion date: Mar 2022 to Jul 2022
    v5
  2. Notable Primary completion date: Feb 2019 to Mar 2021
    • Start date: Jan 2017 to Mar 28, 2017
    • Study completion date: Jan 2020 to Mar 2022
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 4 of 4 sites
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02784119
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)
Liver Transplantation
Enrollment 214 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov