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Elastography in Predicting Renal Outcome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06363032
Enrollment
500
Registered
2024-04-12
Start date
2021-12-27
Completion date
2025-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Keywords

elastography

Brief 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.

Interventions

DIAGNOSTIC_TESTelastography

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

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
collect medical record of blood urea nitrogen and Creatinine3 months and 12 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026