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临床试验/NCT07249268
NCT07249268已完成不适用

Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions: A Propensity Score-Matched Analysis

The First Affiliated Hospital of Xiamen University1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
330
试验地点
1
主要终点
the biopsy success rate

研究概览

简要总结

This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Another method uses a special dye (contrast agent) injected into a vein during the ultrasound, which is called contrast-enhanced ultrasound (CEUS). The dye helps blood vessels and the lesion "light up" on the screen. The researchers wanted to find out if using CEUS leads to a more successful biopsy than using standard US alone.

详细描述

This study compared two different methods used to guide needles during a percutaneous (through the skin) biopsy of a focal liver lesion (a suspicious mass or lump in the liver). The goal was to see if one method was better than the other at ensuring a successful and diagnostic biopsy.

The researchers looked back at the records of 330 patients who had a liver biopsy. Of these, 113 had a CEUS-guided biopsy and 217 had a standard US-guided biopsy. To ensure a fair comparison, they used a statistical method to create two perfectly matched groups of 92 patients each. The patients in these groups were very similar in terms of factors like the size and location of their liver lesion, so that the only major difference was the type of guidance used (CEUS or US).

For most patients with a liver lesion that can be seen on a standard ultrasound, this study suggests that using the more advanced and expensive CEUS method does not increase the chances of a successful biopsy. The standard ultrasound guidance is just as effective.

Therefore, the routine use of CEUS for all liver biopsies may not be necessary. This helps in managing healthcare resources wisely. However, CEUS remains a valuable tool for specific situations where a lesion is very difficult to see clearly on a standard ultrasound scan. Doctors can reserve CEUS for these more challenging cases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Indeterminate liver lesions on prior imaging (CT/MRI).
  • •Coaxial biopsy performed with 18G introducer needle.

排除标准

  • •Coagulopathy (INR >1.5, platelets <50×109/L).
  • •Contraindications to ultrasound contrast agents.

结局指标

主要结局

the biopsy success rate

时间窗: from enrollment to the end of the biopsy

the biopsy success rate of liver lesion

次要结局

  • vasovagal reaction(during the procedure)
  • bleeding(during the procedure)
  • pneumothorax(during the procedure)
  • shock(during the procedure)
  • unplanned hospitalization(48 hours after the surgery)
  • death(48 hours after the surgery)

研究者

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

Lijuan Yan

Principal Investigator

The First Affiliated Hospital of Xiamen University

研究点 (1)

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