Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography

Completed

• Conditions: Kidney Graft

• Registration Number: NCT03819400
• Lead Sponsor: University Hospital, Tours

Brief Summary

Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

Detailed Description

Kidney graft's fibrosis is correlated with prognostic of kidney's graft, wathever the initial etiology. Actually, that evaluation is based on histologic score of Banff FI/AT (0 to III). It is obtained thanks to punction-biopsy, which is invasive and can lead complications. This exam is systematic on M3 of the transplantation.

Tissue's fibrosis is a proliferation of extracellular matrix, leading to an increase of fibrosed tissue rigidity.

Elastography is an ultrasound technique allowing evaluation of tissues' rigidity.

The purpose is the validation of elastograhpy, innovative and non -invasive technique, and more specifically Shear Wave Elastography (SWE). For this, strain ratio (SR) could improve intra-operator variability and estimate fibrosis' degree of kidney's graft.

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-03-29
• Primary Completion: 2022-05-16
• Study Completion: 2022-05-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Kidney-transplanted patient, whatever kind of organ donation ( alive donor, deceased donor included extended criteria Maastricht 2 or 3)
• More than 18 years-old

Exclusion Criteria

• Dual kidney graft

• Hydronephrosis / urinary obstacle

• Pathologies with an intrinsic compression on the graft

• Stenosis hemodynamically significant of graft artery (lengthening of Systolic Ascent Time > 70 ms)

• Contra-indication to systematical punction-biopsy on Month 3 :

  • Ischemia of post-transplanted graft
  • Alive donor HLA identical
  • Hemostasis disorder or unable to stop antiaggregant or anticoagulant
  • Hydronephrosis / urinary obstacle

• Opposition to use the data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measure of shear wave elastography	3 months	Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis

Secondary Outcome Measures

Name	Time	Method
Strain Ratio measure	3 months	- Intra-operator variability of Strain Ratio measure

Trial Locations

Locations (1)

Chu Tours; 🇫🇷 Tours, France