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临床试验/NCT06363032
NCT06363032招募中不适用

Application of Transthoracic Shear-wave Ultrasound Elastography in the Evaluation of Renal Function and Diagnosis of Renal Disease

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年12月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
collect medical record of blood urea nitrogen and Creatinine

研究概览

简要总结

There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.

Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.

In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.

By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260~290) patients is required.

研究设计

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

入排标准

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

入选标准

  • patients receiving scheduled renal biopsy and scheduled renal sonography

排除标准

  • age < 20 y/o, patients who can't hold their breath for at least 5 seconds

结局指标

主要结局

collect medical record of blood urea nitrogen and Creatinine

时间窗: 3 months and 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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