APCext : Effect of Temporary Porto-caval Shunt During Liver Transplantation on Function of Liver Graft From Extended Criteria Donor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 6
- 主要终点
- Incidence of early allograft dysfunction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Complete portal vein thrombosis found during procedure
- •Split liver graft
- •Realisation of a bilio-enteric anastomosis
结局指标
主要结局
Incidence of early allograft dysfunction
时间窗: 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
Incidence of primary non function
时间窗: 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
次要结局
- Evaluation of urinary function(within the first 7 days)
- Patient's survival(at 3 months)
- Liver graft function(within 3 months)
- Realisation of intra-operative transfusion(during the operation)
- Duration of surgery(at day 0)
- Incidence of reperfusion syndrome(during the 5 minutes following revascularisation)
- Occurrence of a severe postoperative complication(within 3 months)
- Graft's survival(at 3 months)