Evaluation of Clinical Feasibility of Microwave Ablation Using Two Channel Microwave Generator and Two Antennas for Small Hepatocellular Carcinoma: A Preliminary Prospective Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Technical success
研究概览
简要总结
To compare safety and efficacy of microwave ablation with simultaneous ablation using two antennas versus overlapping ablation with single antenna for small hepatocellular carcinoma
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child-Pugh Class A or B
- •chronic hepatitis B or chronic hepatitis C or liver cirrhosis
- •presence of hepatocellular carcinoma (HCC) confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
- •single lesion less than or equal to 3 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment
排除标准
- •number of recurrent HCCs, equal or more than 3
- •largest recurrent HCC size over 3 cm
- •presence of vascular invasion by HCC
- •diffuse infiltrative type HCC
- •HCCs located less than 5 mm from central bile duct or large portal vein or large hepatic vein
- •platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
- •presence of extrahepatic metastasis
研究组 & 干预措施
Overlapping ablation with single antenna
干预措施: Microwave ablation (Device)
Simultaneous ablation with two antennas
干预措施: Microwave ablation (Device)
结局指标
主要结局
Technical success
时间窗: Immediately after ablation
Evaluate technical success defined as complete ablation of the index tumor with safety margin, equal or larger than 5 mm on immediate CT.
Technique efficacy
时间窗: 1 month after ablation
Evaluate technical success defined as complete ablation of the index tumor on 1 month follow-up CT.
Number of Participants with Technical Success
时间窗: Immediately after ablation
Technical success is defined as complete ablation of the index tumor with a safety margin equal to or greater than 5 mm, as confirmed on the computed tomography (CT) scan performed immediately after the ablation procedure.
Number of Participants with Technique Efficacy at 1 Month
时间窗: 1 month after ablation
Technique efficacy is defined as the absence of residual or recurrent tumor at the ablation site (indicating complete ablation), as confirmed on the 1-month follow-up computed tomography (CT) scan.
次要结局
未报告次要终点
研究者
Jeong Min Lee
Professor
Seoul National University Hospital