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临床试验/NCT04178759
NCT04178759Unknown不适用

Impact of Chemotherapy and Regenerative Markers on Liver Regeneration After Liver Resection for Liver Metastases

Vilnius University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Volume of regenerated liver after liver resection

研究概览

简要总结

Liver is special organ, which can regenerate. On that ability there are many treatment modalities, where liver resection is performed, especially in cancer patients with liver metastases. Liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. There are many factors that impair liver regeneration. One of these factors is chemotherapy. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

详细描述

Liver is the largest parenchymal organ responsible for over 500 different functions in human body, which are detoxification of various toxins, drugs, synthesis of proteins and enzymes, coagulation factors. Liver is special organ, which can regenerate. If 75% of liver is removed it can regenerate to its normal size. Liver volume is very important to liver function, if there is volume insufficiency it could lead to liver failure in addition to other factors that impair liver regeneration. On that regenerative ability there are many treatment modalities, when liver resection is performed, especially in cancer patients with liver metastases. Modern treatment modalities are based on combination of different treatments, surgical and chemotherapeutic. On the other hand, side effects of chemotherapy should not be discarded, which can increase patient morbidity and mortality. Thus, liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with liver lesions, who are eligible for liver resection

排除标准

  • Pregnant women
  • Liver resection is not performed

结局指标

主要结局

Volume of regenerated liver after liver resection

时间窗: 30 days

Difference of liver volume preoperatively and postoperatively, meassured by CT

次要结局

  • Evaluation of liver fibrosis(30 days)
  • Evaluation of liver markers responsible for liver regeneration(30 days)
  • Evaluation of short term surgical outcomes(90 days)

研究者

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

Kestutis Strupas

Chair of Department of Surgery

Vilnius University

研究点 (2)

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