Validity of Strain Elastography for the Evaluation of Chronic Allograft Nephropathy

Not Applicable

Completed

• Conditions: Chronic Allograft Nephropathy
• Interventions: Diagnostic Test: Elastography arm

• Registration Number: NCT05682313
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2021-01-07
• Primary Completion: 2022-07-13
• Study Completion: 2022-10-24
• Status Verified: 2022-12
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elastography arm	Elastography arm	single arm that includes all patient who have consented for ultrasound elastography

Primary Outcome Measures

Name	Time	Method
Grade of fibrosis	At the time of recruitment	degree of fibrosis obtained by elastography

Trial Locations

Locations (1)

Cairo university hospitals; 🇪🇬 Cairo, Egypt