The Influence of Radiofrequency-assisted Hepatectomy on the Perioperative Outcomes and the Long-term Prognosis of HCC With Cirrhosis：A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative liver injury
研究概览
简要总结
Surgical resection is the most effective treatment of primary and secondary liver tumors. Technical innovations have mainly focused on minimizing bleeding during transection of the hepatic parenchyma because excessive hemorrhage and the need for blood transfusion are associated with increased postoperative morbidity and mortality. Recently,radiofrequency-assisted（RFA）hepatectomy has developed rapidly and gained widespread acceptance for the treatment of hepatocellular carcinomas（HCC），but its influence on the prognosis of HCC patients，especially for those with cirrhosis，is still controversial. Therefore, we design this prospective clinical trial to explore the effect of RFA hepatectomy versus the conventional hepatectomy on the outcomes of perioperative period and prognosis of HCC patients with cirrhosis.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 65 years , no gender restriction.
- •Clinical diagnosis of resectable HCC.
- •Preoperative liver function test showed Child-Pugh Class A or B.
- •Indocyanine green retention at 15 minutes (ICG-15) of <30%.
- •Acceptable clotting profile :platelet count > 50 x 109/L and a prolonged prothrombin time of < 5 seconds.
- •Enough relative residual liver volume (%RLV) ≥ 40%.
- •No tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
- •No other anti-tumor therapy received before the treatment.
- •No metastasis in lymphnode or other organs.
- •Written consent inform assigned.
排除标准
- •Pregnancy.
- •Intraoperative findings of tumor rupture，extrahepatic tumor or lymphnode metastasis.
- •Tumor invasion in primary branch of portal vein, hepatic vein, or inferior vena cava.
结局指标
主要结局
Postoperative liver injury
时间窗: postoperative 90 days
The degree of postoperative hepatic injury is assessed by daily measurements of postoperative aminotransferase (AST) and alanine aminotransferase (ALT) levels, serum bilirubin levels, and prothrombin times. Each patient is followed up within postoperative 90 days.
次要结局
- Number of Participants with Adverse Events(postoperative 90 days)
- Overall survival(1,3,5-year overall survival)
研究者
Li Xiaowu,MD
Dr.Xiaowu Li
Southwest Hospital, China