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临床试验/NCT02967198
NCT02967198已完成不适用

Pre-procedure Planning for Liver Biopsy or Radiofrequency Ablation Using the Automatic Fusion Images of the Registrated 3D CT or MR-US Scans

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US

研究概览

简要总结

The purpose of this study is to determine whether fusion technique of preradiofrequency ablation (RFA) or percutaneous liver biopsy cross-sectional imaging (CT or MR) and real-time ultrasonography would improve feasibility of RFA or liver biopsy in patients with liver tumor in comparison with ultrasonography guidance alone. And assessment of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

详细描述

RFA is one of commonly used local therapies for primary or secondary liver tumors. And percutaneous liver biopsy is very important technique to confirm the diagnosis of focal hepatic lesion whether benign or malignancy.

For successful and safe procedure, safe access route and lesion visibility are essential , and the conditions are usually evaluated on pre-procedure planning ultrasonography (USG). However, these procedure 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 US and CT/MR fusion technique would be able to improve RFA or liver biopsy feasibility in patients with liver tumors in comparison with conventional US alone technique.

In addition, to assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all conditions should be satisfied for inclusion.
  • referred to Radiology in our institution for liver tumor RFA or percutaneous liver biopsy
  • available pre-procedure liver CT or liver MR imaging within 6 weeks

排除标准

  • any contraindication of liver RFA or percutaneous liver biopsy • any patients who received treatment between pre-RFA imaging and planned RFA.

结局指标

主要结局

RFA or biopsy feasibility rates on planning USG with/without fusion CT/MR and US

时间窗: 10 minutes after finishing planning USG

comparison of rates of RFA feasibility on conventional planning USG and on fusion planning USG

Assessment of a new point shear-wave elastography method (pSWE, S-shear wave)

时间窗: 10 minutes after finishing planning USG

To assess intra- and inter-observer reproducibility of a new point shear-wave elastography method (pSWE, S-shear wave) and compare its accuracy in assessing liver stiffness (LS) with another pSWE technique (ARFI).

次要结局

  • Rate of tumor visibility on planning USG with/without fusion technique(10 minutes after finishing planning USG)
  • Number of patients with safety access route on planning USG with/without fusion technique(10 minutes after finishing planning USG)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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