跳至主要内容
临床试验/NCT04487288
NCT04487288Unknown不适用

Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography Compared to Fusion Imaging Alone for Percutaneous Biopsies of Focal Liver Lesions

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
Biopsy yield rate

研究概览

简要总结

So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.

详细描述

Despite the rapid development of tumor markers and liver imaging, pathological confirmation is still necessary for atypical liver lesions that do not meet imaging criteria. US guided procedures are widely used as a method to identify focal lesions of the liver pathologically, and these US guided procedures have no burden on the operation, can be easily accessed, and have a lower cost than surgery. However, the frequency of pathological confirmation with this US guided procedure remains at around 90%. In order to increase this probability, a technique for fusion of liver CT/MRI and US has been widely used in recent years, and this allows accurate targeting of small lesions through structures seen in CT and MR. Through the fusion technique, the biopsy success rate for focal lesions can be increased to 94.4%. However, there are many cases where lesions deeply located in patients with cirrhosis are invisible, and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI. To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion technique, was added, which is a technique that can identify tumor vascularity in real-time using second-generation contrast media. In recent studies, there are studies combining this fusion technique and CEUS technique, and the success rate of these techniques varies from 87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion only technique, the use of CEUS adds cost of contrast media and is limited in patients with side effects on contrast media. . Also, there is no study comparing the two so far, and this study intends to compare the technique combining CEUS and fusion and the technique using only fusion.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for ultrasound biopsy to confirm local liver lesions
  • Adults over 18
  • Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
  • Patients who understand and agree to the explanation and consent form and submit the consent form

排除标准

  • Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
  • Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)

结局指标

主要结局

Biopsy yield rate

时间窗: about 2weeks

Yield rate

次要结局

  • Tumor visibility on B-mode US(immediately)
  • Evaluation of safety access routes to avoid complication(Time: immediately)
  • Tumor vascularity on CEUS(Time: immediately)
  • Complication rate(about 2days)
  • Subjective evaluation on the success of the procedure(immediately)

研究者

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

Jeong Min Lee

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验

Added Value in Combined Use of Fusion Imaging and... | 临床试验