jRCT1070220052招募中不适用
Living donor liver transplantation for unresectable perihilar cholangiocarcinoma
Taizo Hibi0 个研究点目标入组 20 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 主要终点
- 3-year overall survival
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 15age old over 至 70age old not（—）
- 性别
- All
入选标准
- •Unresectable disease but with no extrahepatic metastases and remains progression-free for 3 months or more under neoadjuvant Tx
- •i. Poor hepatic reserve (future liver remnant less than 40%, ICG-R15 10% or more, or ICG-K less than 0.05)
- •ii. Inability to resume portal vein/arterial inflow due to extensive vascular invasion
- •iii. Extensive longitudinal spread along the biliary tree precluding R0 resection
- •iv. Cholangiocarcinoma arising in the setting of PSC with poorly-defined localization
- •Conditions fit for living donor liver transplantation
- •a) Age, 15-69
- •b) ECOG performance status, 0 or 1
- •c) Laboratory data that meet the following:
- •i. Neutrophil: 1,500/microliter or more
- •ii. Platelet: 30,000/microliter or more
- •iii. Hb: 7.5g/dL or more
- •iv. Cr: 1.5mg/dL or more
- •v. New York Heart Association (NYHA) classes I and II
- •vi. Hugh-Jones classes I and II
- •d) Documented informed consent from the participant
排除标准
- •Presence of intra and extrahepatic metastases
- •Presence of Lymph node metastases
- •Malignancies other than perihilar cholangiocarcinoma
- •Presence of uncontrolled infection
- •Adverse events Grade 4 or more (CTCAE v5.0) due to neoadjuvant therapy
- •Other conditions that are clinically unfit for the study
结局指标
主要结局
3-year overall survival
时间窗: 3 years
Overall survival after living donor liver transplantation for unresectable (includes borderline resectable) perihilar cholangiocarcinoma
次要结局
- Short-term outcomes after living donor liver transplantation (LDLT)
研究者
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