射频消融与腹腔镜肝切除术治疗小肝细胞癌的疗效和安全性：一项随机对照试验方案。
Efficacy and safety of radiofrequency ablation versus laparoscopic hepatectomy for small hepatocellular carcinoma: A protocol for a randomized controlled trial.
机构信息
Department of General Surgery, The Ninth People's Hospital of Chongqing, Chongqing, China.
出版信息
Medicine (Baltimore). 2021 Jan 8;100(1):e23678. doi: 10.1097/MD.0000000000023678.
BACKGROUND
Hepatocellular carcinoma (HCC) is one of the most common type of malignant tumors in adults, and is the most common cause of death in people with cirrhosis. Both laparoscopic hepatectomy (LH) and radiofrequency ablation (RFA) are radical treatments for small HCC. However, there is no international standard for the treatment of small HCC, and it is still controversial to choose LH or RFA in treating small HCC. We try to carry out a randomized, controlled, prospective study to compare the the short-term and long-term effects and safety of LH versus RFA in the treatment of small HCC.
METHODS
This study is a single-center, evaluator-blinded, randomized, controlled clinical trial (RCT). The patients will be randomly divided into RFA group and LH group in a 1:1 ratio according to a computer-generated randomization list. Postoperative complications rates, Alpha fetoprotein (AFP), hospital stay, 1, 2, 3-year overall survival (OS) rates, disease-free survival (DFS) rates and all possible adverse events will be recorded. Statistical analyses will be performed with SPSS v22.0 software.
CONCLUSIONS
The study will compare the the short-term and long-term effects and safety of LH versus RFA in the treatment of small HCC.
OSF REGISTRATION NUMBER
doi: 10.17605/OSF.IO/HNX2T.
背景
肝细胞癌（HCC）是成人中最常见的恶性肿瘤之一，也是肝硬化患者死亡的最常见原因。腹腔镜肝切除术（LH）和射频消融（RFA）都是小 HCC 的根治性治疗方法。然而，对于小 HCC 的治疗尚无国际标准，选择 LH 或 RFA 治疗小 HCC 仍存在争议。我们试图开展一项随机、对照、前瞻性研究，比较 LH 与 RFA 治疗小 HCC 的短期和长期疗效及安全性。
方法
这是一项单中心、评估者设盲、随机、对照临床试验（RCT）。患者将根据计算机生成的随机分组列表以 1:1 的比例随机分为 RFA 组和 LH 组。记录术后并发症发生率、甲胎蛋白（AFP）、住院时间、1、2、3 年总生存率（OS）、无病生存率（DFS）和所有可能的不良事件。统计分析将使用 SPSS v22.0 软件进行。
结论
该研究将比较 LH 与 RFA 治疗小 HCC 的短期和长期疗效及安全性。
OSF 注册号：doi: 10.17605/OSF.IO/HNX2T。
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