A Randomized Controlled Trial to Compare the Outcomes Between Hepatectomy and Transarterial Chemoembolization for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System
详细描述
Multiple hepatocellular carcinomas (HCCs) accounts for 60% to 70% of patients with hepatocellular carcinoma.However,the selection criteria of hepatectomy for patients with multiple HCCs remains controversial.Researches have suggested that part of the patients with multiple HCCs can also benefit from hepatectomy.But,expanding the selection criteria for hepatectomy will increase tumor recurrence rates and reduce the therapeutic effect, more stringent selection criteria will also make part of the patients who should take hepatectomy lose the operation chance. This is a difficult problem in the research of this field.The Barcelona Clinic Liver Cancer (BCLC) system recommends that stage A (number ≤ 3, largest diameter ≤ 3 cm) were suitable for liver resection.However, increasing reports on good outcome after hepatectomy for patients with multiple HCCs have been published.Studies on clonal origin suggest that hepatectomy is a better treatment for multiple HCCs from multicentric origin (MO) than that from intrahepatic metastasis (IM) and the 5-year overall survival rates is 24% to 58%.The investigators established a scoring system(NDR score; N, tumor number; D, total tumor diameter; R, ratio of largest/smallest diameter) based on preoperative data which can accurately predict postoperative long-term survival of patients with multiple HCCs.The formula is as follows: 1×N(N: >3=1; ≤3= 0)+ 2×D(D: >8cm = 1; ≤8cm= 0)+ 1×R(R: >6 = 1; ≤6= 0).The investigators first propose a selection criteria of hepatectomy for patients with multiple HCCs based on this scoring system. Patients with a NDR score 0-2 are recommended for hepatectomy and can benefit from the surgery,and because of the unsatisfied outcome,patients with a NDR score more than 2 are not recommended for hepatectomy.The stringent selection criteria should be expanded so that more patients can benefit from hepatectomy,and the less stringent criteria should be limited to ensure curative effect.So,the investigators' NDR scoring system was more accurate in selecting patients with multiple HCCs for hepatectomy and this article was published on Ann Surg Oncol(2015,22:826).In order to further confirm the rationality of this selection criteria,the investigators would like to propose a prospective randomized controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients > 18 years and <=70 years of age
- •Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD).
- •Preoperative ECOG criteria score of 0-1
- •Child-Pugh class A liver function
- •Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm
排除标准
- •Major portal/hepatic vein invasion
- •Extrahepatic metastasis
- •Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- •Anticancer treatment before surgery
- •Lost to follow-up
结局指标
主要结局
overall survival
时间窗: 5 years
次要结局
- Time to recurrence(5 years)
研究者
ShenFeng
vice president of the Eastern Hepatobiliary Surgery Hospital
Eastern Hepatobiliary Surgery Hospital
