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临床试验/NCT03762876
NCT03762876Unknown不适用

Evaluation of Trans-Hepatic Flow Changes in Major Hepatectomy-THEFLOW Study

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Portal vein flow

研究概览

简要总结

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.

详细描述

Liver resection is an efficient treatment for primary and secondary hepatic tumors and increases long term survival. Improvements in patient selection criteria, surgical methods, and postoperative care have increased the indications for major and extended hepatectomy (EH). Post-hepatectomy liver failure (PHLF) is a major complication following EH and is called small for size and flow syndrome (SFSF). SFSF significantly increases morbidity and mortality. The current SFSF treatments are not effective because tissue damage following SFSF is irreversible and the liver parenchyma loses the ability to regenerate. The best approach to improve patient survival is to predict SFSF and perform adequate preventive procedures during liver resection. SFSF is caused by changes in trans-hepatic flow and a low future liver remnant volume. Portal vein flow (PVF), hepatic artery flow (HAF), and portal vein pressure (PVP) are the main criteria for SFSF development. Following EH, the ratio of HAF to the remnant liver weight (HAF/100gr) decreases, while the PVF/100gr and the PVP increase. This has various pathologic consequences, which lead to SFSF. Troisi et al. suggested an upper limit of 250 ml/min/100g for PVF to prevent SFSF after living donor liver transplantation. A vascular modulation that decreases the PVF/100gr and PVP and increases the HAF/100gr may prevent SFSF. The mechanisms that alter trans-hepatic flow after hepatectomy and living donor transplantation are similar, but the effect of these changes on SFSF has not been studied following liver resection. Exploring the changes in trans-hepatic flow after major and extended hepatectomy and determining the factors that influence these changes would allow us to modulate hepatic inflow during hepatectomy to prevent PHLF.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patient consent
  • Undergoing major or central liver resection
  • Aged above 18 years

排除标准

  • 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

结局指标

主要结局

Portal vein flow

时间窗: One day

次要结局

  • Portal vein pressure(One day)
  • Hepatic artery flow(One day)
  • Central vein pressure(One day)
  • Mean arterial pressure(One day)
  • Post-hepatectomy liver failure(Three months)
  • Rate of morbidity(Three months)
  • Rate of mortality(Three months)
  • Grade of liver stiffness(Three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. A. Mehrabi

Professsor, Head of the Division of Liver Surgery and Visceral Transplantation

University Hospital Heidelberg

研究点 (1)

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