Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Disease-free survival
研究概览
简要总结
Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:
- Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA
- What is the risk factor for ablation or surgery in treating iCCA
- What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically diagnosed iCCA based on the WHO classifications;
- •curative-intent liver resection or microwave ablation;
- •tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
- •age ≥18 years.
排除标准
- •Patients not meeting any one of the inclusion criteria were excluded.
结局指标
主要结局
Disease-free survival
时间窗: More than 3 years
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
Overall survival
时间窗: More than 3 years]
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
次要结局
未报告次要终点
研究者
Ping Liang
Professor
Chinese PLA General Hospital