Resection And Partial LIver Transplantation With Delayed Hepatectomy for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patient with successful RAPID procedure
研究概览
简要总结
This is a national, non-randomized, multicentric trial evaluating the feasibility and the tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring a liver transplantation.
详细描述
In France, the liver transplant allocation is based on the severity of liver failure, but patients with hepatocellular carcinoma (HCC) usually do not have hepatocellular failure, resulting in reduced access to liver transplantation. Two years after registration on the LT list, only 66% of those registered are transplanted due to tumor progression. This observation leads to the paradoxical conclusion that better access to transplantation is an absolute priority, but remains limited by the shortage of grafts.
The split surgical of one graft into two grafts is the most effective way to increase the number of transplantable organs. This technique is performed daily as part of pediatric TH where the child receives the left lobe/liver, adapted to his morphology. However, in adults, transplantation of the left lobe (segments 2+3) or of the left liver (segments 2+3+4) associated with complete excision of the native liver generates a high rate of complications (small-for-size syndrome) and compromises graft and recipient survival. For these reasons, this type of procedure has been almost abandoned in France.
One of the ways to increase the organ pool without risking liver failure is therefore to perform an auxiliary transplant with a partial graft from an organ harvested in its entirety and then shared.
The investigators therefore wish to evaluate the feasibility and tolerance, the results and the "gain" of grafts after a standardized RAPID procedure ( Resection And Partial LIver Transplantation with Delayed Hepatectomy) allowing to transplant an adult with a left lobe (very small graft) from a shared whole graft (deceased donor in brain death) , and to compare the results with standard management (orthotopic HT with whole organ for HCC).
The population is 50 major patients (in order to realize the RAPID procedure for 34 patients) with HCC requiring LT according to the usual transplantability criteria, with preserved liver function. The study lasts a maximum of 70 months (24 months of inclusion period, 6 months between selection and inclusion, <12 months between inclusion and the 1st RAPID time, 4 months maximum between the 2 RAPID Steps, 24 months of patient follow-up post 2nd step of RAPID). The study will proceed as described below :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of patient with successful RAPID procedure
时间窗: 4 months after the second RAPID step
Success of the procedure will be assessed as a patient : * who complete the 2 steps of the procedure, * who had no graft resection and who is still alive 4 months later.
Tolerance of the RAPID procedure
时间窗: from first stage of the surgical protocol and until 90 days after the second stage
Tolerance will be assessed with Adverse events related to the procedure
次要结局
- Proportion of grafts in place(4 months after the first surgical step)
- Survival of patient at 2 year after their registration on the waiting list of transplantation(at 2 year after their registration on the waiting list of transplantation)
- Incidence of rejection after RAPID(at 2 years after the first stage of RAPID)
- Waiting time between listing on the waiting list and LT according to RAPID(1 year)
- Survival of grafts at 2 years from liver transplantation (LT)(at 2 Years from LT)
- Gain of grafts(70 months)
- Comparison of the graft survival at 2 years after LT between RAPID group and control group(at 2 years after 1rst stage of RAPID)
- Survival of patient at 2 year after LT(at 2 year after LT)
- Comparison of the waiting time between registration on the transplantation list and LT between RAPID group and control group(up to 18 months)
- Comparison of the drop-out rate between RAPID group and control group(18 months)