跳至主要内容
临床试验/NCT07302152
NCT07302152已完成不适用

Evaluation of Elastosonographic Techniques Implemented on Ultrasound Systems for the Assessment of Liver Stiffness

Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年3月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
elastosonographic

研究概览

简要总结

The assessment of liver stiffness is essential in patients with suspected or confirmed chronic liver disease, as clinical management depends on the degree and progression of hepatic fibrosis, which increases liver hardness. In recent years, non-invasive elastosonographic techniques have been introduced to estimate liver fibrosis. The first to be implemented was Transient Elastography (TE), which has shown high accuracy in identifying significant fibrosis and cirrhosis, particularly in patients with HCV-related chronic liver disease, and has been endorsed by The European Association for the Study of the Liver (EASL) guidelines as an alternative to liver biopsy. More recently, shear-wave elastography techniques integrated into conventional ultrasound systems have been developed, offering the advantage of real-time B-mode ultrasound guidance. The aim of this study is to compare these techniques with each other and with TE.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years, ability to hold breath during image acquisition, informed consent.

排除标准

  • any condition that, in the investigator's clinical judgment, would make further participation in the study unacceptable for that individual patient.

结局指标

主要结局

elastosonographic

时间窗: up to 24 months

Measurement taken in the right intercostal space, median value of 5 measurements for 2D shear wave and 10 measurements for point shear wave.

次要结局

未报告次要终点

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluigi Poma

Principal Investigator

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (2)

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