跳至主要内容
临床试验/NCT02654028
NCT02654028已完成不适用

Association Between Autologous Transfusion and Recurrence-free Survival in Patients With Hepatocellular Carcinoma After Resection-a Prospective Non-randomized Controlled Trial

Guangxi Medical University1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 2019年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
618
试验地点
1
主要终点
Number of participants with tumor recurrence

研究概览

简要总结

This prospective non-randomized controlled trial aims to determine whether autotransfusion of red blood cells salvaged before liver resection is associated with the recurrence-free survival in patients with hepatocellular carcinoma.

详细描述

Preoperative and intraoperative blood salvage autotransfusion is used in various surgical procedures. However, because of the risk of reinfusion of salvaged blood contaminated by tumor cells, the use of autotransfusion in hepatocellular carcinoma (HCC) patients undergoing liver resection is controversial. The critical points include whether tumor cells can be cleared by autotransfusion, whether autotransfusion increases the risk of recurrence or metastasis, and what are the indications for autotransfusion. Moreover, some other issues are still not addressed. For example, is it warranted to take the risk of tumor dissemination by using autotransfusion to avoid allogeneic blood transfusion? Do the remaining tumor cells after additional filtration by leukocyte depletion filters still possess potential tumorigenicity?

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent liver resection;
  • Diagnosis of hepatocellular carcinoma confirmed by postoperative histopathology;
  • Level of preoperative hemoglobin ≥110 g/L;
  • Child-Pugh class A or B liver function;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.

排除标准

  • A history of other malignancies;
  • History of active autoimmune or immunodeficiency diseases;
  • Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
  • Loss to follow-up.

结局指标

主要结局

Number of participants with tumor recurrence

时间窗: 1-year

The 1-year tumor recurrence will be compared between the two groups

次要结局

未报告次要终点

研究者

发起方
Guangxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian-Hong Zhong

Director

Guangxi Medical University

研究点 (1)

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