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临床试验/NCT03766555
NCT03766555招募中不适用

Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
76
试验地点
1
主要终点
Overall survival

研究概览

简要总结

We propose a randomized controlled study to compare the treatment efficacy of microwave ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline liver function.

详细描述

Hepatocellular carcinoma (HCC) is a common cancer and is diagnosed at an earlier stage and with increasing frequency because of the wider implementation of screening programs. Whether liver resection or local ablation should be the first-line treatment in early HCC remains a hot topic for debate. Both are regarded as acceptable curative treatment for early HCC in many international guidelines. Underlying liver function is the key in treatment selection. The general consensus is that liver resection should be the treatment of choice in patients with good liver function while local ablation should be considered in patients with poor liver function. There exists a group of patients with apparently good liver function that harbor significant liver cirrhosis which is not easily picked up by the current assessment or scoring systems. Liver resection in this group of patients is burdened by potentially life-threatening complications and the overall survival is limited by their underlying liver cirrhosis. This is particularly important in early HCC as local ablation is another curative treatment option. In order to improve the prognosis of patients with early HCC, it is important to identify (1) patients with liver dysfunction to the extend that the risk of liver resection will outweigh the survival benefit it provides; (2) the best ablative method for HCC.

The investigators propose to carry out a prospective randomized controlled study to compare the treatment outcome of microwave ablation with liver resection in patients with borderline liver function whose HCC that are amendable to both liver resection and microwave ablation.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • HCC amendable for both MWA and liver resection
  • Liver function of ALBI Grade 2
  • Tumour size </= 5cm
  • Absence of extrahepatic metastasis
  • Absence of radiology evidence of major vascular or bile duct invasion

排除标准

  • Informed consent not available
  • Patients with ALBI 3, Child-Pugh B or above
  • Multifocal tumour
  • Presence of portal vein or hepatic artery thrombosis
  • Anticipation of concomitant procedures
  • Emergency hepatectomy
  • Ruptured HCC
  • Patients with chronic renal failure
  • Pregnant female patients

结局指标

主要结局

Overall survival

时间窗: 5 years

The primary outcome of this study is the overall survival

次要结局

  • Recurrence rate(5 years)
  • Disease-free survival(5 years)
  • Hospital stay(1 year)
  • Morbidity rate(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charing Chong, MD

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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