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

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT03819400
Collaborator
(none)
100
Enrollment
1
Location
59.1
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography
    Actual Study Start Date :
    Mar 29, 2019
    Anticipated Primary Completion Date :
    Dec 25, 2023
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. measure of shear wave elastography [3 months]

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

    Secondary Outcome Measures

    1. Strain Ratio measure [3 months]

      - Intra-operator variability of Strain Ratio measure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chu Tours Tours France 37044

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT03819400
    Other Study ID Numbers:
    • RIPH3-RNI18-Elastogreffe
    First Posted:
    Jan 28, 2019
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Tours
    kidney graft
    fibrosis
    elastography
    Additional relevant MeSH terms:
    Fibrosis

    Study Results

    No Results Posted as of Jan 13, 2022