使用近红外光谱诊断和量化肝脏脂肪变性 (STEATO-NIR)
In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Currently, expanded criteria donors account for 75% of liver transplants, whereas in 2009 they accounted for less than 30% of liver transplants.
Steatosis and its progression Non-alcoholic steatohepatitis (NASH) is an emerging disease in industrialised countries due to obesity, and corresponds to the accumulation of intracytoplasmic triglycerides.
Steatosis is diagnosed when this fat content represents more than 5% of the total liver mass. There are two types of steatosis: microvesicular steatosis and macrovacuolar steatosis, defined by the presence of lipid droplets larger than the nucleus with a nucleus displaced to the periphery. Macrovacuolar steatosis is responsible for impaired liver function if it is present in ≥30% of hepatocytes. It is a factor in poor prognosis for liver transplants, with reduced graft and recipient survival and an increase in early graft dysfunction after liver transplantation. The quantification of hepatic steatosis is based on the pathological analysis of a liver biopsy, which is currently the gold standard.
This technique has disadvantages: it is an invasive method, requiring an experienced pathologist, and presents inter-individual variability in the assessment and quantification of steatosis.
It is therefore essential to develop new non-invasive diagnostic tools that can identify the presence of steatosis > 5% and ≥ 30%. Several non-invasive techniques for diagnosing steatosis have been studied: Fibroscan, CT scan, MRI, but none of those studied previously allow for the accurate quantification of hepatic steatosis, particularly macrovacuolar steatosis, with instant results.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sophie Chopinet, Dr
- 电话号码:+33 0491435817
- 邮箱:promotion.interne@ap-hm.fr
学习地点
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-
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Marseille、法国、13005
- Timone Hospital
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接触:
- Sophie Chopinet
- 电话号码:+33 0491435817
- 邮箱:promotion.interne@ap-hm.fr
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Liver grafts:
- Men or women aged 18 and over
- All donors accepted by the MA4FC procurement team, including brain-dead donors and Maastricht 3 donors, even if placed on a perfusion machine
- Donors whose families have received information about the study and have not expressed any opposition
Surgical specimens (hepatectomy):
- Men or women aged 18 years and older
- Subjects who have undergone surgery for any indication of hepatectomy
- Affiliated with social security,
- Having received information about the study and not having expressed opposition
Exclusion Criteria:
Liver grafts:
- Donors whose liver will be subject to a SPLIT procedure
- Donors for whom there is a medical-legal obstacle
- Donors whose family or loved ones oppose scientific sampling: The hospital coordination team will consult the national refusal register and question loved ones to determine whether the deceased would have opposed sampling. If the donor and/or family oppose scientific sampling, then sampling will not be performed.
Surgical specimens (hepatectomy):
- Subjects covered by Articles L1121-5 to 1121-8 of the Public Health Code (minors, adults under guardianship or curatorship, patients deprived of their liberty, pregnant or breastfeeding women),
- Subjects who do not understand the French language
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:肝移植物
|
Scan of the liver via near-infrared spectrometer |
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实验性的:手术标本(肝切除术)
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Scan of the liver via near-infrared spectrometer |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensibility of near-infrared spectroscopy
大体时间:through study completion, an average of 1 year
|
Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (>5%). |
through study completion, an average of 1 year
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
近红外光谱的特异性
大体时间:从入组到研究结束(12个月时)
|
从入组到研究结束(12个月时)
|
|
近红外光谱的约登指数
大体时间:从入组至研究结束(12个月)
|
从入组至研究结束(12个月)
|
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近红外光谱的似然指数 + 和 -
大体时间:从入组至研究结束(12个月时)
|
从入组至研究结束(12个月时)
|
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近红外光谱的纳克似然比
大体时间:从入组至研究结束(12个月)
|
从入组至研究结束(12个月)
|
|
近红外光谱的ROC曲线
大体时间:从入组至研究结束(12个月时)
|
从入组至研究结束(12个月时)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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