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

NCT ID: NCT03819400

Last Updated: 2024-04-23

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

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-29

Study Completion Date

2022-05-16

Brief Summary

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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

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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.

Conditions

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Kidney Graft

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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RIPH3-RNI18-Elastogreffe

Identifier Type: -

Identifier Source: org_study_id

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