Clinical trial NCT03819400: Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography
Official title: Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Graft
Keywords: kidney graft
fibrosis
elastography
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney-transplanted patient

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.

Eligibility criteria: 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

Primary outcomes:
measure: measure of shear wave elastography
timeFrame: 3 months
Secondary outcomes:
measure: Strain Ratio measure
timeFrame: 3 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Chu Tours
Study officials:
References: