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临床试验/NCT03490461
NCT03490461已完成不适用

Effects of Statin on Hepatocellular Carcinoma Recurrence After Liver Transplantation

Yonsei University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2017年11月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
1
主要终点
A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.

研究概览

简要总结

This study aims to investigate whether statin therapy can help prevent recurrence of hepatocellular carcinoma (HCC) in transplant recipients who had liver transplantation for HCC. Multiple logistic regression analysis will be performed to evaluate the association between statin therapy and the risk of HCC recurrence after LT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who received LT at the Severance Hospital from 2006 to 2016.

排除标准

  • early postoperative mortality (defined as death within 2 months after LT without signs of tumor recurrence)
  • patient with distant lymph node metastasis confirmed within 1 month after LT
  • Patients younger than 20 years of age
  • patients who had LT for cirrhosis without confirmed HCC

研究组 & 干预措施

Statin group

Statin therapy was defined as the administration of statins for more than 30 days after liver transplantation

干预措施: Statin (Drug)

结局指标

主要结局

A new lesion with radiographic features compatible with HCC was defined as recurrence of HCC.

时间窗: up to December, 2017

Usually, liver CT is performed at 1 week, 1 month, 6 months, and every year until 5 years after surgery. Afterwards, liver CT is performed at 2-year intervals. Measurement of blood tumor markers \[AFP and prothrombin induced by vitamin K absence-II\] is performed every month for 6 months after discharge from the hospital and every 3 months thereafter. Additional liver CT, liver magnetic resonance imaging, or positron emission tomography-CT is performed when elevated tumor markers or suspicious lesions were noted. A new lesion with radiographic features compatible with HCC is defined as recurrence of HCC based on the reports of specialist in radiology.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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