Assessment of the Real-time CT/MR-US Automatic Fusion System Using Vascular Matching in Pre-procedure Planning for Radiofrequency Ablation: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 主要终点
- Technical success rate of the overall RFA procedure
研究概览
简要总结
To prospectively evaluate the technical success rate of real-time computed tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by automatic fusion in hepatocellular carcinoma (HCC) patients.
详细描述
RFA is one of commonly used local therapies for primary or secondary liver tumors. For successful and safe procedure, safe route of electrode and lesion visibility are essential for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG). However, RFA is sometimes aborted due to limited sonic window of various cause and challenging identification of small isoechoic tumors or hepatocellular carcinomas among dysplastic nodules . Therefore, precise targeting and assuring safe route would be of clinical importance. In this preliminary study, investigators attempted to determine automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients with liver tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic or typical imaging based diagnosis of HCC
- •Multiphase CT or MRI within 3 months ahead of procedure
- •No evidence of distant metastasis
- •No contraindications for conventional RFA procedure in our institute, which are uncontrolled coagulopathy (international standard ratio ≥ 1.6, or platelet > 50,000), poor cooperation, unfeasible for sedation, portal vein tumor thrombus, tumor number >4, largest tumor size > 5cm, and tumors abutting portal vein or bile ducts bigger than segmental branches.
排除标准
- •Lack of multiphase CT or MRI withing 3 months ahead of procedure
- •RFA planned for palliative purpose
- •Diagnosed as non-HCC malignancy
- •Right hepatectomy state
结局指标
主要结局
Technical success rate of the overall RFA procedure
时间窗: immediately after RFA procedure
Absolute technical success rate of the overall RFA compared to literature
Rate of complete ablation of the tumor after 1 month clinical follow up
时间窗: 1 month after the RFA procedure
Rate of complete ablation of the tumor after 1 month clinical follow up compared to literature
Technical success rate of the fusion process
时间窗: Immediately after fusion process
Absolute technical success rate of the fusion process
次要结局
- Technical feasibility before and after the fusion process(10 minutes after finishing planning USG)
- Local tumor progression rate(During post procedural follow up to 5 years)
- Safety of the approach route before and after the fusion process(10 minutes after finishing planning USG)
- Tumor visibility before and after the fusion process(10 minutes after finishing planning USG)
研究者
Jeong Min Lee
Professor
Seoul National University Hospital