Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-10-24

Brief Summary

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Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis.

In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biops

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Detailed Description

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Chronic allograft nephropathy is one of dreaded complication of kidney transplant. It is one of the major determinants of long term graft survival. There are a number of factors that can contribute to chronic allograft nephropathy including chronic use of calcineurin inhibitors. Renal biopsy is the investigation of choice to detect chronic renal allograft nephropathy. renal biopsy has a number of complications . This includes infection and bleeding. The non invasive renal sono-elastography (strain and Shear Wave Imaging) technique has shown very good yield of detecting and scoring fibrosis.

In this study our aim is to determine the sensitivity and specificity of ( strain sono-elastography) in the detection and classifying of chronic allograft nephropathy as compared to transcutaneous renal biopsy

Conditions

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Chronic Allograft Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Elastography arm

single arm that includes all patient who have consented for ultrasound elastography

Group Type EXPERIMENTAL

Elastography arm

Intervention Type DIAGNOSTIC_TEST

Renal ultrasound elastography to detect and classify the degree of fibrosis

Interventions

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Elastography arm

Renal ultrasound elastography to detect and classify the degree of fibrosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Renal transplant patients of more than 2 years duration, Chronic allograft nephropathy proved by renal biopsy done within 1 month from the date of the strain elastography, Body mass index less than 30 kg/m2, Skin allograft distance of less than 3.5 cm, Parenchyma thickness of more than 1 cm and no fluid accumulation around the allograft.

Exclusion Criteria

Body mass index more than 30 kg/m2, Skin allograft distance more than 3.5 cm, Parenchymal thickness less than 1 cm, Presence of any fluid collection around the allograft, GFR less than 15 ml/min, Graft stones or backpressure and less than 14 years old or more than 55 years old.

Minimum Eligible Age

14 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No