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临床试验/NCT03881410
NCT03881410已完成不适用

The Efficacy of Shear-wave Elastography-guided Aspiration and Biopsy for Diagnosis in Lung Tumor: a Randomized Controlled Trial

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2019年5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
已完成
入组人数
413
试验地点
1
主要终点
The diagnostic yield between two groups

研究概览

简要总结

To use the shear-wave elastography to assist the transthoracic ultrasound-guided aspiration biopsy of peripheral lung tumor

  1. To identify the intra-tumor heterogeneity of elasticity
  2. To increase the diagnostic yield in ultrasound-guided transthoracic biopsy of subpleural pulmonary tumor

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •(1) Patients with radiographic evidence of pulmonary lesions

排除标准

  • •Age < 20 y/o
  • •Patients who cannot hold their breath for 5 seconds
  • •Inadequate shear-wave propagation of lung tumor

研究组 & 干预措施

Shear-wave elastography-guided

Experimental

Shear-wave elastography-guided bipsy

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

Convention ultrasound-guided

Active Comparator

Convention ultrasound-guided biopsy

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

结局指标

主要结局

The diagnostic yield between two groups

时间窗: 6 months

sensitivity, specificity, positive predictive value, and negative predictive value

次要结局

  • Procedure duration(1 day)
  • Complication rate(1 day)
  • Total times of the biopsy(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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