CT引导下直肠癌根治术后局部复发冷冻消融治疗的单臂单中心临床研究

CT-guided cryoablation of local recurrence of rectal carcinomas after radical resection: a single arm and single center clinical study

目的:直肠癌的局部复发是接受根治性手术切除患者治疗失败的主要原因之一,本研究旨在探索直肠癌根治术后局部复发冷冻消融治疗的可行性、安全性及有效性。方法:2013年10月—2016年8月共入组31例直肠癌根治术后局部复发患者,行36次冷冻消融术,术后随访16～50个月。治疗后影像学随访采用盆腔增强CT或磁共振成像(magnetic resonance imaging,MRI),分析技术成功率、并发症发生及处理情况、1年内局部病灶控制率及总生存期(overall survival,OS)。患者疼痛程度采用数字评分法(numerical rating scale,NRS),比较术前、术后患者疼痛评分及肿瘤标志物癌胚抗原(carcinoembryonic antigen,CEA)水平。结果:本研究技术成功率为100%,主要并发症发生率为16.7%。1年内局部病灶控制率为61.3%,局部病灶无进展期为(15.1±1.8)个月,OS为(17.9±2.3)个月。患者术前、术后第3天和术后12个月NRS疼痛评分分别为(4.3±2.4)分、(1.4±1.2)分和(4.5±2.7)分,术前与术后第3天NRS疼痛评分差异有统计学意义(P=0.001),术前与术后12个月NRS疼痛评分差异无统计学意义(P=0.854)。术前与术后12个月CEA分别为(54.9±85.4) ng/mL和(67.2±82.7) ng/mL,差异无统计学意义(P=0.558)。结论:CT引导下冷冻消融作为一种治疗直肠癌根治术后局部复发的新方法,可行性强,安全性较高,局部病灶控制率高,短期内疼痛缓解明显,但是否有长期生存获益仍需进一步的随机对照研究。

Objective:The local recurrence is one of the main reasons of treatment failure for rectal carcinomas after radical resection.The present study aimed to investigate the feasibility,safety,and efficacy of CT-guided cryoablation of local recurrence of rectal carcinomas after radical resection.Methods:From October 2013 to August 2016,a total of 31 patients were enrolled in this study,and a follow-up of 16-50 months was performed.Contrast-enhanced CT or magnetic resonance imaging (MRI)of pelvic was used during follow-up.The technical success rate,complications and managements,1-year local control rate and overall survival (OS)were recorded.Score of numerical rating scale (NP,S)was adopted to assess the pain degree before and after cryoablation. The value of tumor biomarker of carcinoembryonic antigen (CEA)was compared between pre-ablation and post-ablation.Results: The technical success rate was 100% and the main complication rate was 16.7%.The l-year local control rate was 61.3%,time to progression-free of local lesion was (15.1±1.8)months,and overall survival was (17.9±2.3)months.NRS score of pre-ablation, 3-day post-ablation and 12-month post-ablation was 4.3±2.4,1.4±1.2and 4.5±2.7,respectively.NRS score had significant difference between pre-ablation and 3-day post-ablation (P=0.001),and there was no significant difference between pre-ablation and 12-month post-ablation (P=0.854).CEA of pre-ablation and 12-month post-ablation was (54.9±85.4)ng/mL and (67.2±82.7)ng/ mL,without significant difference (P=0.558).Conclusion:CT-guided cryoablation as a new method for local recurrence of rectal carcinomas after radical resection is safe and feasible,has high rate of local control,and could relieve pain obviously in the short term.However,the overall survival benefits still need more randomized controlled trials.