跳至主要内容
临床试验/NCT06226909
NCT06226909招募中不适用

The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2024年1月15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
234
试验地点
1
主要终点
The diagnostic yield of the two groups

研究概览

简要总结

To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • •Patients with radiographic evidence of pleural disease

排除标准

  • •Age < 18 y/o
  • •Patients who cannot hold their breath for 5 seconds

研究组 & 干预措施

Shear-wave elastography-guided

Experimental

based on the shear-wave elastography, the area with the highest elasticity value will be the target area to perform pleural biopsy for at least 6 times

干预措施: different types of ultrasound technique (Procedure)

B-mode ultrasound-guided

Active Comparator

based on the B-mode transthoracic ultrasound, the area with the maximal thickness will be the target area to perform pleural biopsy for at least 6 times

干预措施: different types of ultrasound technique (Procedure)

结局指标

主要结局

The diagnostic yield of the two groups

时间窗: 6 months

the pathology of pleural biopsies will be interpreted by cytopathologists

次要结局

  • Procedure time(1 day)
  • the rate of pneumothorax & hemothorax(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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