内镜射频消融术治疗无法手术切除壶腹癌的长期随访研究

A long term follow-up study of endoscopic radiofrequency ablation for unresectable ampullary carcinoma

目的探索内镜射频消融术治疗无法手术切除壶腹癌的远期效果。方法回顾性收集2012年1月—2019年5月在海军军医大学第三附属医院接受内镜射频消融术治疗的壶腹癌患者临床资料,包括基本信息、射频消融次数、胆管支架类型、术后并发症及随访情况。采用Kaplan-Meier方法分析患者在内镜射频消融术治疗后的生存情况,分析射频消融次数、胆管支架类型与总体生存时间的关系。结果共纳入50例患者,男31例,女19例,年龄为(73.0±9.7)岁。25例(50.0%)患者进行过1次射频消融治疗,25例(50.0%)患者进行过≥2次射频消融治疗;6例(12.0%)患者出现术后并发症,均为轻症。平均随访时间22.3个月,共有39例(78.0%)患者死亡,5例(10.0%)患者失访,6例(12.0%)患者存活。患者中位总体生存时间为16.9(95%CI:9.1~24.8)个月,一年、二年、三年和五年累积生存率分别为62.0%、38.5%、27.0%和12.6%。射频消融治疗≥2次的患者中位总体生存时间较治疗1次的患者有延长趋势,但差异无统计学意义[26.7(95%CI:9.7~43.7)个月比12.6(95%CI:4.9~20.3)个月,χ^(2)=3.049,P=0.081]。32例(64.0%)患者采用塑料支架,18例(36.0%)采用金属支架,采用金属支架和采用塑料支架患者的中位总体生存时间差异无统计学意义[17.1(95%CI:6.1~28.0)个月比15.9(95%CI:6.9~24.9)个月,χ^(2)=0.029,P=0.865]。结论内镜射频消融术是治疗无法手术切除壶腹癌的一种安全疗法,多次连续治疗有可能增加生存获益。

Objective To explore the long-term effect of endoscopic radiofrequency ablation for the treatment of unresectable ampullary carcinoma.Methods Clinical data of patients with ampullary carcinoma who received endoscopic radiofrequency ablation in the Third Affiliated Hospital of Naval Medical University from January 2012 to May 2019 were retrospectively collected,including basic information,frequency of radiofrequency ablation,the type of biliary stent,postoperative complications,and follow-up.Kaplan-Meier method was used to analyze the survival of patients after endoscopic radiofrequency ablation.Relationship between frequency of radiofrequency ablation,type of biliary stent and overall survival time was analyzed.Results A total of 50 patients were enrolled,including 31 males and 19 females,aged 73.0±9.7 years.Twenty-five patients(50.0%)underwent 1 radiofrequency ablation treatment,while 25 patients(50.0%)underwent radiofrequency ablation treatments more than twice.Postoperative complications occurred in 6 patients(12.0%),all of which were mild symptoms.The average follow-up was 22.3 months,with a total of 39(78.0%)deaths,5(10.0%)lost to follow-up,and 6(12.0%)surviving.The median overall survival time was 16.9(95%CI:9.1-24.8)months,with cumulative survival rates of 62.0%,38.5%,27.0%,and 12.6%at 1,2,3,and 5 years,respectively.The median overall survival time of those treated with radiofrequency ablation≥2 times showed a trend of prolongation compared to patients treated once,but the difference was not statistically significant[26.7(95%CI:9.7-43.7)months VS 12.6(95%CI:4.9-20.3)months,χ^(2)=3.049,P=0.081].Plastic stents were used in 32 patients(64.0%)and metal stents in 18 patients(36.0%).There was no significant difference in median overall survival time between patients using metal and plastic stents[17.1(95%CI:6.1-28.0)months VS 15.9(95%CI:6.9-24.9)months,χ^(2)=0.029,P=0.865].Conclusion Endoscopic radiofrequency ablation is a safe treatment for unresectable ampullary carcinoma,and multiple consecutive treatments may increase the survival benefit.