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Completed

NCT Number: NCT03819400

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

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.

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Key information

Conditions

Kidney Graft Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. measure of shear wave elastography

    Time frame: 3 months

    Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis

Secondary outcomes

  1. Strain Ratio measure

    Time frame: 3 months

    • Intra-operator variability of Strain Ratio measure

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: Elastogreffe

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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