腹腔镜肝切除术和射频消融术治疗复发性肝癌的前瞻性随机对照研究(中期随访分析)

Laparoscopic hepatectomy versus radiofrequency ablation in treatment of recurrent hepatocellular carcinoma: a prospective randomized control study based on interim follow-up analysis

目的比较腹腔镜肝切除术(laparoscopic hepatectomy,LH)与射频消融术(radiofrequency ablation,RFA)治疗复发性肝癌的围术期及术后生存结果,为复发性肝癌患者治疗方式选择提供高级别循证医学证据。方法 2016年9月至2017年9月共入组80例复发性肝癌患者,通过随机数字表法随机分至LH组和RFA组。应用前瞻性随机对照研究,分析两组患者围术期指标及总体生存期和无瘤生存期,通过COX比例风险模型分析影响患者术后再次复发的危险因素。结果中期随访结果显示,LH组与RFA组患者的平均生存期差异无统计学意义[(19.3±6.8)月vs(18.6±6.2)月,P=0.293]。LH组患者1、2年总体生存率为:92.3%和89.7%,RFA组为:85.4%、80.5%。LH无瘤生存期与RFA比较差异有统计学意义[(16.4±8.5)月vs(8.3±7.2)月,P=0.000]。两组1、2年无瘤生存率分别为LH:69.2%、51.3%,RFA:26.8%、22.0%。COX比例风险模型分析显示手术方式及患者术前甲胎蛋白(alpha fetoprotein,AFP)水平是影响患者再次复发的危险因素。结论中期随访结果显示,对选择性复发肝癌患者,腹腔镜肝切除术后2年无瘤生存率高于射频消融术。

Objective To compare the perioperative and postoperative survival outcomes of laparoscopic hepatectomy(LH) and radiofrequency ablation(RFA) in the treatment of recurrent hepatocellular carcinoma(RHCC) in order to provide high-level evidence-based medical evidence for the treatment. Methods From September 2016 to September 2017, a total of 80 RHCC patients were prospectively enrolled and randomly assigned to the LH and RFA groups. A prospective randomized controlled study was used to analyze perioperative factors, overall survival and disease-free survival of patients between the 2 groups, and COX proportional risk model was used to analyze the risk factors for postoperative recurrence. Results According to this interim follow-up analysis, there was no significant difference in the overall survival time between the LH group and the RFA group(19.3±6.8 vs 18.6±6.2 months, P=0.293). The 1-and 2-year overall survival rates were 92.3% and 89.7% in the LH group and 85.4% and 80.5% in the RFA group. There was statistical significant difference in disease-free survival time between the LH group and the RFA group(16.4±8.5 vs 8.3±7.2 months, P=0.000). The 1-year and 2-year disease-free survival rates were 69.2% and 51.3% in LH group, and 26.8% and 22.0% in RFA group. COX proportional risk model analysis showed that the surgical procedures and preoperative alpha fetoprotein(AFP) level were the risk factors for re-recurrence. Conclusion Our interim follow-up analysis shows that, in selective RHCC patients, LH has a better 2-year disease-free survival rate than RFA.