Study of Factors Predicting Tumor Recurrence After Liver Transplantation for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Predictive factors of HCC recurrence
研究概览
简要总结
Results of liver transplantation, the best theoretical treatment for HCC, are limited by tumor recurrence. In order to limit this risk Milan criteria was proposed in 1996. However, these criteria are to restrictive and approximately 40% of patients denied by Milan criteria may be cured by liver transplantation.
The purpose of this study was thus to prospectively evaluate factors predicting tumor recurrence after liver transplantation for HCC and then to reassess criteria for liver transplantation.
详细描述
In this study, the investigators studied the predictive value of imaging techniques such as CT, MRI, PET scan, of serological markers and molecular markers assessed before liver transplantation at listing.
The investigators also evaluated the predictive value of tumor growing during the waiting time (imaging and serological).
Finally, the investigators compared pre-LT data and explanted liver analysis to evaluate accuracy of liver biopsy and of imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis
- •Hepatocellular carcinoma diagnosed by AASLD criteria or liver biopsy
- •Listing for Liver transplantation for HCC fulfilling or not Milan criteria
- •No extra-hepatic spread
- •No vascular involvement
排除标准
- •Salvage transplantation
- •Transplantation contra-indication
- •Evaluation for Liver transplantation older than 1 month
- •Incidental HCC
结局指标
主要结局
Predictive factors of HCC recurrence
时间窗: at 2 years after Liver transplantation for HCC (modified by amendment on 17/10/2013)
次要结局
- Predictive factors of overall survival at 5 years(at 5 years)
- Correlation of HCC differentiation between liver biopsy and explant liver(at 32 month)
- Predictive factors of drop-out(during the waiting time)
- Radio-pathological correlation(end of the study)
- Predictive factors of tumor-free recurrence(at 3 years)