NCT03647059Unknown不适用
Real-time Noninvasive Assessment of Donor Liver Quality
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年8月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- LSCM examination results
研究概览
简要总结
Aims：
- Conduct multi-center, prospective and open research on liver quality assessment and establish LSCM liver quality assessment system
- Classification of liver quality grades by LSCM for different pathological conditions (steatosis, fibrosis, hepatocyte necrosis, etc.)
- Compare the specificity and sensitivity of LSCM evaluation results with the results of liver donor quality evaluation and intraoperative pathological biopsy results.
- LSCM classifies the quality of donor liver and compares the recovery of liver function on the first day after liver transplantation.
- LSCM grades the quality of donor liver and compares the long-term prognosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All donor livers to be used for liver transplantations
排除标准
- •Exclusion of multiple organ transplantation
- •Exclusion of detached transplantation and partial liver transplantation, etc.
- •Removal of blood type incompatible patients for transplantation
- •Exclusion of poor donor liver quality due to surgical technique (such as hepatic artery embolization) , portal vein thrombosis, etc.)
- •Any form of substance abuse, mental illness or any disease that the investigator believes may interfere with the patient's understanding of the research requirements.
- •Can not complete routine research follow-up, and other circumstances that the investigator believes are not suitable for the experiment.
结局指标
主要结局
LSCM examination results
时间窗: 1 day
LSCM examination is focus on the detections of the hepatocyte nucleus and the micro structures(such as the micro-circulation、central vein and so on).
次要结局
- HE section staining pathological examination(1 week)
研究者
Lin Zhong
Director of hepatobiliary surgery
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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