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临床试验/NCT06833619
NCT06833619招募中不适用

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Sohag University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

研究概览

简要总结

Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.

Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.

However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test

排除标准

  • •Using anti-platelets or anticoagulants within the last 5days
  • •Inability to provide informed consent
  • •Moderate-to-gross ascites
  • •Child C cirrhosis
  • •INR more than 2.01
  • •Platelet count less than 50,000/µL3

研究组 & 干预措施

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Other

干预措施: Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique (Device)

结局指标

主要结局

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

时间窗: -Study period: Duration of the study will be 12 months after acceptance of The Ethical Committee Of The Medical Research. All patients will sign an informed written consent before starting the data collection with respect to patient's confidentiality.

Measurement the efficacy of liver biopsy specimens by European Association for the Study of Liver Disease (EASL) criteria . - Total Specimen Length (TSL) of more than or equal to 15 mile-meters.

次要结局

未报告次要终点

研究者

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

Sara Elbadry Elrabie

Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Sohag University

研究点 (1)

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