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

Обзор

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.

Вмешательства

• Процедура temporary porto-caval shunt
  temporary porto-caval shunt

Первичные конечные точки

• Incidence of early allograft dysfunction [Срок оценки: on postoperative day 7]
• Incidence of early allograft dysfunction [Срок оценки: within the 7 first postoperative day]
• Incidence of primary non function [Срок оценки: within the 7 first postoperative day]

Вторичные конечные точки (8)

• Realisation of intra-operative transfusion [Срок оценки: during the operation]
• Incidence of reperfusion syndrome [Срок оценки: during the 5 minutes following revascularisation]
• Duration of surgery [Срок оценки: at day 0]
• Liver graft function [Срок оценки: within 3 months]
• Occurrence of a severe postoperative complication [Срок оценки: within 3 months]
• Evaluation of urinary function [Срок оценки: within the first 7 days]
• Graft's survival [Срок оценки: at 3 months]
• Patient's survival [Срок оценки: at 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Complete portal vein thrombosis found during procedure
• Split liver graft
• Realisation of a bilio-enteric anastomosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Франция · 6 центров

• CHU Bordeaux — Bordeaux
• Hospices Civils Lyon — Lyon
• CHU Nice — Nice
• CHU Rennes — Rennes
• CHU Toulouse — Toulouse
• CHU Tours — Tours

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗