Association Between Autologous Transfusion and Recurrence-free Survival in Patients With Hepatocellular Carcinoma After Resection-a Prospective Non-randomized Controlled Trial
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
- 是
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
Jian-Hong Zhong
Director
Guangxi Medical University
