The Intention-to-treat Effect of Bridge Therapies in the Setting of Milan-in Patients
The Intention-to-treat Effect of Bridging Therapies in the Setting of Milan-in Patients Waiting for Liver Transplantation
研究概览
详细说明
Liver transplantation (LT) is the best curative treatment of hepatocellular cancer (HCC) developed in an underlying liver disease. LT is considered as an oncologic successful procedure when a long-term post-transplant tumour-free survival is obtained. Conversely, a failure is equal to pre-transplant drop-out, post-transplant tumour recurrence or death. Due to the allograft scarcity, a HCC patient waiting for a LT is most often treated using neo-adjuvant loco-regional therapies (LRT) in order to minimise the risk of drop-out. When the tumour burden meets the Milan Criteria (MC) at moment of diagnosis, such an approach is called "bridging towards LT".
Two recent international guidelines underlined the importance of the bridging strategy, due to its potential to reduce the risk of pre-LT drop-out and post-LT recurrence. This is especially valid in the case in which a partial/complete tumour response is achieved before LT. Unfortunately, the quality of the evidence obtained from the currently available literature is low due to the lack of randomized controlled trials (RCT). Actually, it is inconceivable to realize RCT in this setting because of logistical and, even more, ethical reasons. Consequently, the majority of reported studies just compare post-LT outcome of treated and untreated patients, failing thereby to analyse the clinical course from an intention-to-treat (ITT) point of view.
Even when looking at studies including the waiting list period, one should keep in mind that substantial differences may exist among initially bridged vs untreated HCC patients regarding tumour burden. In order to overcome these limits, a retrospective analysis of a large European population of MC-IN HCC patients listed for LT was done. After "balancing" this cohort with an inverse probability of treatment weighting (IPTW), we investigated the risk factors for tumour-specific LT failure, especially focusing at the role of LRT.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Brussels、比利时
- UCL
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- adults (≥18-year old) listed for liver transplant with a morphologic and/or histologic confirmed hepatocellular cancer
Exclusion Criteria:
- Milan Criteria-out status at first referral
- transplantation or de-listing before January 1, 2001
- other means of loco-regional treatments such as partial hepatectomy, trans-arterial radio-embolization or external radiotherapy
- misdiagnosed mixed hepatocellular-cholangiocellular cancer or cholangiocellular cancer
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:追溯
队列和干预
团体/队列 |
干预/治疗 |
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Direct liver transplant
All the cases listed for liver transplantation and then transplanted/dropped-out without undergoing any neo-adjuvant loco-regional treatment
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Direct liver transplant (no neoadjuvant approaches during the waiting time period)
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Bridging followed by transplant
All the cases listed for liver transplantation and then transplanted/dropped-out after undergoing at least one neo-adjuvant loco-regional treatment
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Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Tumour-specific liver transplant failure rate
大体时间:up to 5 years from first referral
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Any case of tumor-related drop-out during the waiting list period or post-transplant recurrence
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up to 5 years from first referral
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合作者和调查者
调查人员
- 首席研究员:Quirino Lai, MD PhD、UCL Brussels
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Direct liver transplant的临床试验
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Institute of Cancer Research, United KingdomCancer Research UK; University of Manchester; University of Sussex完全的
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Stanford UniversitySanta Clara Valley Medical Center撤销
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Novartis Pharmaceuticals完全的