Elastography in Predicting Renal Outcome

NCT06363032 | Unknown

• 1 other identifier: 202110104RINB
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Disease

Keywords

elastography

Outcome Measures

Primary Outcomes (1)

• collect medical record of blood urea nitrogen and Creatinine

  3 months and 12 months

Interventions

elastography DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients receiving scheduled renal biopsy and scheduled renal sonography

You may qualify if:

• patients receiving scheduled renal biopsy and scheduled renal sonography

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: April 12, 2024
• Study Start: December 27, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2023-12

Locations

TW (1)