Evaluation of Kidney Graft's Fibrosis With Real Time Shear-wave Elastography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- measure of shear wave elastography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney-transplanted patient, whatever kind of organ donation ( alive donor, deceased donor included extended criteria Maastricht 2 or 3)
- •More than 18 years-old
排除标准
- •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
结局指标
主要结局
measure of shear wave elastography
时间窗: 3 months
Evaluation of shear wave elastography real time as biomarker of kidney graft's fibrosis
次要结局
- Strain Ratio measure(3 months)