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

Kidney Graft Clinical Trial

— Elastogreffe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819400
• Other study ID #: RIPH3-RNI18-Elastogreffe
• Status: Completed
• Start date: March 29, 2019
• Est. completion date: May 16, 2022

Study information

• Verified date: April 2024
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 16, 2022
• Est. primary completion date: May 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Kidney Graft

Locations

Country	Name	City	State
France	Chu Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure of shear wave elastography	Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis	3 months
Secondary	Strain Ratio measure	- Intra-operator variability of Strain Ratio measure	3 months