Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy (THEFLOW)
Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study
Changes in trans-hepatic flow after major and extended hepatectomy (EH) can lead to small for size and flow syndrome (SFSF), which is associated with a significantly higher rate of morbidity and mortality. The current therapies for SFSF are not effective because tissue damage following SFSF is usually irreversible and the liver parenchyma loses the ability to regenerate. Therefore, the best approach to improve patient survival is to predict SFSF and perform adequate intraoperative preventive procedures.
Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for development of SFSF after living donor liver transplantation. The mechanisms that change trans-hepatic flow are similar after hepatectomy and living donor liver transplantation. Trans-hepatic flow is routinely measured during liver resection, but the effect of these changes on SFSF has not been studied. Identifying the factors that alter trans-hepatic flow after hepatectomy would allow hepatic inflow to be modulated before and after surgery, to prevent SFSF.
Trans-hepatic flow and pressure parameters (PVF, HAF, and PVP) are routinely measured and monitored during liver resection. The aim of the proposed study is to analyze changes in these parameters after major hepatectomy and determine the factors that alter trans-hepatic flow after hepatectomy.
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Baden-Württemberg
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Heidelberg、Baden-Württemberg、德国、69120
- 招聘中
- Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Patient consent
- Undergoing major or central liver resection
- Aged above 18 years
Exclusion Criteria:
- Cirrhosis
- Previous surgery of the hepatoduodenal ligament
- Status after transjugular intrahepatic portosystemic shunt
- Metabolic liver diseases
- Cardiac failure
- Pulmonary hypertension
- Portal vein thrombosis
- Portal vein hypertension
- Vascular malformation
- Not able to give consent
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Portal vein flow
大体时间:One day
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One day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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发病率
大体时间:三个月
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基于 Clavien-Dindo 分类
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三个月
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死亡率
大体时间:三个月
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全因死亡事件
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三个月
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Portal vein pressure
大体时间:One day
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Vein pressure (mmHg)
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One day
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Hepatic artery flow
大体时间:One day
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One day
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Central vein pressure
大体时间:One day
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Vein pressure (mmHg)
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One day
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Mean arterial pressure
大体时间:One day
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One day
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Post-hepatectomy liver failure
大体时间:Three months
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Based on the ISGLS criteria
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Three months
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Grade of liver stiffness
大体时间:Three months
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Via fibroscan before and after resection
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Three months
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合作者和调查者
调查人员
- 首席研究员:Mohammad Golriz, MD、Department of General, Visceral and Transplant Surgery, University Hospital
- 研究主任:Arianeb Mehrabi, MD、Department of General, Visceral and Transplant Surgery, University Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
与本研究相关的术语
其他研究编号
- S-576/2017
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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