内镜引导下射频消融术治疗恶性胆道梗阻的前瞻性临床研究
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摘要
目的了解内镜引导下射频消融术(RFA)治疗恶性胆道梗阻患者的可行性及安全性。方法采用前瞻性对照研究的方法,选择2017年4月至2018年4月在我院确诊为手术不可切除的恶性胆道梗阻患者作为研究对象,随机分成两组,一组患者接受经内镜逆行胰胆管造影(ERCP)的胆道RFA治疗,随后置入胆道自膨式金属支架(SEMS),记为RFA组;另一组患者单纯置入胆道SEMS,记为支架组。术后长期随访直至患者死亡或者研究结束。比较2组的临床和技术成功率、并发症发生率、支架通畅时间和总生存期(OS),并分析影响支架通畅和OS的相关因素。结果 RFA组和支架组的技术成功率均为100%,临床成功率分别为95%和90%。两组的并发症中没有与RFA治疗相关的严重并发症,且并发症发生率差异无统计学意义(P> 0.05)。RFA组和支架组的中位支架通畅时间分别为173、142 d,差异无统计学意义(P> 0.05)。而在支架通畅率方面,治疗6个月后,RFA组的支架通畅率高于支架组,差异有统计学意义(P <0.05)。RFA组和支架组患者的中位生存期分别为259、234 d,RFA组的生存期显著延长,差异有统计学意义(P <0.05)。在影响支架通畅时间和OS相关因素的单变量和多变量Cox回归分析中,术前胆管炎均是影响支架通畅的独立危险因素,而RFA治疗次数(≥2次)是OS的独立预测因素。结论内镜引导下RFA是一种技术上安全和有效的治疗方案,可用于恶性胆道梗阻的姑息性治疗。
Objective Evaluate the feasibility and safety of endoscopic radiofrequency ablation in the treatment of patients with malignant biliary obstruction. Methods Prospective controlled study methods were used,the patients with unresectable malignant biliary obstruction diagnosed in our hospital from April 2017 to April2018 were selected as the object of study. They were randomly divided into two groups. One group of patients were treated with biliary RFA through ERCP,followed by implanted biliary SEMS,which was referred to as the RFA group,while the other group was treated with implanted biliary SEMS alone,which was referred to as the stent group. long-term follow-up until the death of the patient or the end of the study. The clinical and technical success rate,complication incidence rate,stent patency time and OS were compared between the two groups,and the related factors of stent patency and OS were analyzed. Results The technical success rate of RFA group and stent group was 100%,while the technical success rate of stent group was 95% and 90%,respectively. There were no serious complications associated with RFA treatment in the two groups,and there was no significant difference in the incidence of complications(P > 0.05). The median patency time of stent in the RFA group and the stent group was173 days and 142 days respectively,and there were no significant differences(P > 0.05). In terms of stent patency rate,the rate of stent patency in the RFA group was higher than that in the stent group 6 months after treatment,and there were significant differences(P < 0.05). The median OS of the RFA group and the stent group was259 days and 234 days respectively. The OS in the RFA group was significantly prolonged,and there were significant differences(P < 0.05). Univariate and Multivariate Cox Regression Analysis were used to examine the risk factors associated with stent patency time and OS,preoperative cholangitis was an independent risk factor for stent patency,and RFA treatment times(≥ 2 times)were independent predictive factors of OS. Conclusions Endoscopic radiofrequency ablation is a technically safe and effective therapeutic schedule,which can be used as palliative treatment for malignant biliary obstruction.
Objective Evaluate the feasibility and safety of endoscopic radiofrequency ablation in the treatment of patients with malignant biliary obstruction. Methods Prospective controlled study methods were used,the patients with unresectable malignant biliary obstruction diagnosed in our hospital from April 2017 to April2018 were selected as the object of study. They were randomly divided into two groups. One group of patients were treated with biliary RFA through ERCP,followed by implanted biliary SEMS,which was referred to as the RFA group,while the other group was treated with implanted biliary SEMS alone,which was referred to as the stent group. long-term follow-up until the death of the patient or the end of the study. The clinical and technical success rate,complication incidence rate,stent patency time and OS were compared between the two groups,and the related factors of stent patency and OS were analyzed. Results The technical success rate of RFA group and stent group was 100%,while the technical success rate of stent group was 95% and 90%,respectively. There were no serious complications associated with RFA treatment in the two groups,and there was no significant difference in the incidence of complications(P > 0.05). The median patency time of stent in the RFA group and the stent group was173 days and 142 days respectively,and there were no significant differences(P > 0.05). In terms of stent patency rate,the rate of stent patency in the RFA group was higher than that in the stent group 6 months after treatment,and there were significant differences(P < 0.05). The median OS of the RFA group and the stent group was259 days and 234 days respectively. The OS in the RFA group was significantly prolonged,and there were significant differences(P < 0.05). Univariate and Multivariate Cox Regression Analysis were used to examine the risk factors associated with stent patency time and OS,preoperative cholangitis was an independent risk factor for stent patency,and RFA treatment times(≥ 2 times)were independent predictive factors of OS. Conclusions Endoscopic radiofrequency ablation is a technically safe and effective therapeutic schedule,which can be used as palliative treatment for malignant biliary obstruction.
引文
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[11]马莹,蔡维.ERCP、MRCP联合中医辩证施治在肝外胆道梗阻性疾病诊治中的应用[J].现代消化及介入诊疗,2017,22(5):666-668.
[12]LI T F,HUANG G H,LI Z,et al.Percutaneous transhepatic cholangiography and intraductal radiofrequency ablation combined with biliary stent placement for malignant biliary obstruction[J].J Vasc Interv Radiol,2015,26(5):715-721.
[13]MONGA A,GUPTA R,RAMCHANDANI M,et al.Endoscopic radiofrequency ablation of cholangiocarcinoma:new palliative treatment modality(with videos)[J].Gastrointest Endosc 2011,74(4):935-937.
[14]DROMI S A,WALSH M P,HERBY S,et al.Radiofrequency ablation induces antigen-presenting cell infiltration and amplification of weak tumor-induced immunity[J].Radiology 2009,251(1):58-66.
[15]TENG L S,JIN K T,HAN N,et al.Radiofrequency ablation,heat shock protein 70 and potential anti-tumor immunity in hepatic and pancreatic cancers:A mini review[J].Hepatobiliary Pancreat Dis Int,2010,9(4):361-365.
[2]RAMIREZ-MERINO N,AIX S P,CORTES-FUNES H.Chemotherapy for cholangiocarcinoma:An update[J].World J Gastrointest Oncol,2013,5(7):171-176.
[3]LOEW B J,HOWELL D A,SANDERS M K,et al.Comparative performance of uncoated,self-expanding metal biliary stents of different designs in 2 diameters:Final results of an international multicenter,randomized,controlled trial[J].Gastrointest Endosc,2009,70(3):445-453.
[4]DOLAK W,SCHREIBER F,SCHWAIGHOFER H,et al.Endoscopic radiofrequency ablation for malignant biliary obstruction:A nationwide retrospective study of 84 consecutive applications[J].Surg Endosc,2014,28(3):854-860.
[5]SHARAIHA R Z,NATOV N,GLOCKENBERG K S,et al.Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures:Is there an added benefit[J].Dig Dis Sci,2014,59(12):3099-3102.
[6]KALLIS Y,PHILLIPS N,STEEL A,et al.Analysis of endoscopic radiofrequency ablation of biliary malignant strictures in pancreatic cancer suggests potential survival benefit[J].Dig Dis Sci,2015,60(11):3449-3455.
[7]LAQUIèRE A,BOUSTIèRE C,LEBLANC S,et al.Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma[J].Surg Endosc,2016,30(3):1242-1248.
[8]LALEMAN W,VAN DER MERWE S,VERBEKE L,et al.Anew intraductal radiofrequency ablation device for inoperable biliopancreatic tumors complicated by obstructive jaundice:The IGNITE-1 study[J].Endoscopy,2017,49(10):977-982.
[9]YANG J,WANG J,ZHOU H,et al.Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma:A randomized trial[J].Endoscopy,2018,50(8):751-760.
[10]武玉强,胡泽民,何坤.公民逝世后器官捐献供肝移植胆道并发症的预防经验[J].器官移植,2017,8(4):299-303.
[11]马莹,蔡维.ERCP、MRCP联合中医辩证施治在肝外胆道梗阻性疾病诊治中的应用[J].现代消化及介入诊疗,2017,22(5):666-668.
[12]LI T F,HUANG G H,LI Z,et al.Percutaneous transhepatic cholangiography and intraductal radiofrequency ablation combined with biliary stent placement for malignant biliary obstruction[J].J Vasc Interv Radiol,2015,26(5):715-721.
[13]MONGA A,GUPTA R,RAMCHANDANI M,et al.Endoscopic radiofrequency ablation of cholangiocarcinoma:new palliative treatment modality(with videos)[J].Gastrointest Endosc 2011,74(4):935-937.
[14]DROMI S A,WALSH M P,HERBY S,et al.Radiofrequency ablation induces antigen-presenting cell infiltration and amplification of weak tumor-induced immunity[J].Radiology 2009,251(1):58-66.
[15]TENG L S,JIN K T,HAN N,et al.Radiofrequency ablation,heat shock protein 70 and potential anti-tumor immunity in hepatic and pancreatic cancers:A mini review[J].Hepatobiliary Pancreat Dis Int,2010,9(4):361-365.