Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial
Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial
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DOI：
10.1007/s00432-013-1568-0
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发表时间：
2014-02-01
影响因子：
3.6
通讯作者：
Liu, QingXin
中科院分区：
文献类型：
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作者：
Yang, MinJie;Fang, ZhuTing;Liu, QingXin
目的肝癌合并门静脉肿瘤血栓形成（PVTT）尚无标准治疗方法。这项前瞻性、随机、双臂临床试验旨在探讨经动脉化疗栓塞（TACE）联合血管内植入碘-125种子链治疗肝癌合并门静脉肿瘤血栓形成的可行性、安全性和有效性，与传统TACE相比。患者和方法85例符合入选条件的患者随机分为TACE联合血管内植入碘125种子链43例和常规TACE 42例。终点是生存时间、与手术相关的并发症和不良事件。结果两组患者基线特征无显著差异。A组的平均生存期和中位生存期分别为221.7 +/- 16.3天[95%可信区间（CI） 189.8-253.6天]和210.0 +/- 17.5天（95% CI 175.8-244.2天），B组的平均生存期分别为155.1 +/- 7.9天（95% CI 139.6-170.5天）和154.0 +/- 11.2天（95% CI 133.2-176.0天）（P = 0.000）。A组90、180、360 d的累计生存率分别为97.6%、58.9%、12.3%，B组为92.5%、30.7%、0% （P = 0.000）。结论经动脉化疗栓塞联合血管内植入125碘粒子束治疗肝癌合并PVTT是可行、安全、有效的。
Purpose There was no standard treatment for hepatocellular carcinoma with portal vein tumour thrombosis (PVTT). This prospective, randomised, two-arm clinical trial aims to investigate the feasibility, safety and effectiveness of transarterial chemoembolisation (TACE) combined with the endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus conventional TACE.Patients and methods Eighty-five patients who met the eligibility requirements were randomly assigned to receive the treatment of TACE combined with the endovascular implantation of an iodine-125 seed strand (43 cases) or conventional TACE (42 cases). The end points were survival time, complications related to the procedure and adverse events.Results No significant differences in baseline characteristics were observed between groups. The mean and median survival times were 221.7 +/- 16.3 days [95% confidence interval (CI) 189.8-253.6 days] and 210.0 +/- 17.5 days (95 % CI 175.8-244.2 days) in group A and 155.1 +/- 7.9 days (95 % CI 139.6-170.5 days) and 154.0 +/- 11.2 days (95 % CI 133.2-176.0 days) in group B (P = 0.000). The 90-, 180-and 360-day cumulative survival rates were 97.6, 58.9 and 12.3 % in group A and 92.5, 30.7 and 0 % in group B (P = 0.000).Conclusion Transarterial chemoembolisation combined with the endovascular implantation of an iodine-125 seed strand is feasible, safe and effective in the treatment for hepatocellular carcinoma with PVTT.