Clinical Trial

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

Study acronym: APCext
Recruiting
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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.
Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2016-05-23; most recent amendment 2024-09-20.
Status change: Not Yet Recruiting → Recruiting 2017-11-14
Trial Details
NCT Number NCT02784119
Lead Sponsor Rennes University Hospital
Conditions Liver Transplantation
Enrollment 214 participants
Start Date 2017-03-28
Primary Completion 2025-07 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2024-09-23