跳至主要内容
临床试验/NCT05361538
NCT05361538招募中不适用

A Single-center, Prospective Randomized Controlled Study of Microwave Spherical Ablation and Traditional Microwave Ablation in the Treatment of Single Hepatocellular Carcinoma With a Diameter of ≤5cm

Tianjin Third Central Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月22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
60
试验地点
1
主要终点
Comparison of progression-free survival between MSA and traditional MWA in HCC

研究概览

简要总结

Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm.

详细描述

HCC is a serious threat to the health of people,Early treatment of HCC results in a good prognosis for patients. Microwave ablation (MWA) is an important method for the treatment of early HCC. The traditional MWA technology has a long diameter of the ablation foci which is much larger than the transverse diameter, so in order to obtain a sufficient transverse diameter, the long diameter is often too large beyond the tumor boundary. That will cause too much normal liver tissue is unnecessarily damaged, especially for patients with severe liver cirrhosis or patients with liver cirrhosis who have undergone liver resection. In addition, it is easy to cause damage to adjacent vital tissues and organs. Changes in tissue properties during ablation affect the stability of the microwave field, resulting in unpredictable ablation shapes, which may cause omissions during tumor ablation, especially in multiple overlapping ablation, resulting in incomplete ablation, or increasing the risk of local tumor progression after treatment. Microwave spherical ablation (MSA) technology is a new MWA technology. With the help of temperature control technology, field control technology and wave control technology, a single needle can produce predictable spherical ablation lesions. Theoretically, MSA can improve the controllability of the ablation foci, which is suitable for the purpose of conformal ablation of large tumors in clinical practice, thereby minimizing the damage of local thermal ablation to liver tissue and adjacent important organs. However, there are few reports on the comparison of the therapeutic effect of MSA and traditional MWA. This study intends to conduct a prospective randomized controlled study based on the two mature microwave treatment methods of MSA and traditional MWA ablation to explore the effectiveness and safety of MSA in clinical application, providing evidence-based medical evidence for the clinical application of MSA.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ;
  • Age range 18 to 75 years old;
  • Single lesion with tumor diameter ≤5cm;
  • Patient refuses surgery and determines to undergo microwave ablation
  • Liver function Child Pugh A or B;
  • No extrahepatic metastasis or portal invasion;
  • Patient signs the informed consent.

排除标准

  • The lesion has received treatment, including local ablation therapy and TACE therapy, etc;
  • With portal vein invasion or extrahepatic metastases;
  • Patient is with severe cardiopulmonary insufficiency.
  • Patient is a pregnant or breastfeeding women.
  • Patient is considered to be unsuitable to participate in the study

结局指标

主要结局

Comparison of progression-free survival between MSA and traditional MWA in HCC

时间窗: 6 to 12 months

Compare the time to tumor progression after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm

次要结局

  • Comparison of the overall survival of MSA and traditional MWA in HCC(12 to 60 months)
  • Comparison of complete ablation rates of MSA and traditional MWA in HCC(1 month)
  • Comparison of the complications rate of MSA and traditional MWA in HCC(immediately)
  • Comparison of local progression rates of MSA and traditional MWA in HCC(6 to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验