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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03819400
Acronym
Elastogreffe
Enrollment
45
Registered
2019-01-28
Start date
2019-03-29
Completion date
2022-05-16
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Graft

Keywords

kidney graft, fibrosis, elastography

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.

Interventions

None listed

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
measure of shear wave elastography3 monthsEvaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis

Secondary

MeasureTime frameDescription
Strain Ratio measure3 months\- Intra-operator variability of Strain Ratio measure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026