Elastography in Predicting Renal Outcome

Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363032
• Other study ID #: 202110104RINB
• Status: Recruiting
• Start date: December 27, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• patients receiving scheduled renal biopsy and scheduled renal sonography

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases

Intervention

Diagnostic Test:
• elastography
When routine renal ultrasound is arranged, patients will be invited to receive elastography at the same time.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	collect medical record of blood urea nitrogen and Creatinine		3 months and 12 months