HabibHabib EndoHPB EndoHPB -双极射频消融导管双极射频消融导管恶性胆道梗阻治疗新技术恶性胆道梗阻治疗新技术1内容提要内容提要1.射频及其在肿瘤临床中的应用；2.Endo-HPB是什么及其操作方法；3.Endo-HPB主要作用及其临床应用；4.Endo-HPB临床效果；2什么是射频什么是射频n射频（RF，Radio Frequency）就是射频电流，它是一种高频交流变化电磁波的简称。n频率范围从300KHz300GHz之间。n每秒变化小于1000次的称为低频电流，大于10000次的称为高频电流，而射频就是这样一种高频电流。高频高频(大于大于10K)；射频（射频（300K-300G）是高频的较高频段；）是高频的较高频段；微波频段（微波频段（300M-300G）又是射频的较高频段。）又是射频的较高频段。3正常组织正常组织急性热凝固急性热凝固凝固性坏死凝固性坏死1.1.通过通过460460千赫电流，千赫电流，RFRF射频能量从发生射频能量从发生器转移到射频电极。器转移到射频电极。2.2.RFRF射频能量使电极射频能量使电极附近的细胞内物质附近的细胞内物质快速振荡（离子搅快速振荡（离子搅动）。动）。3.3.离子搅动引起摩擦离子搅动引起摩擦加热，该热量又在加热，该热量又在电极针临近的组织电极针临近的组织上传递扩散，从而上传递扩散，从而导致细胞死亡。导致细胞死亡。肿瘤射频消融原理肿瘤射频消融原理4温度与细胞死亡温度与细胞死亡（肿瘤细胞对温度更为敏感）（肿瘤细胞对温度更为敏感）（肿瘤细胞对温度更为敏感）（肿瘤细胞对温度更为敏感）5射频消融在美国、欧洲、亚太肝病学会指南，射频消融可以与手术射频消融在美国、欧洲、亚太肝病学会指南，射频消融可以与手术一样，作为肝癌根治疗性治疗手段。一样，作为肝癌根治疗性治疗手段。AASLDPRACTICEGUIDELINE2010AASLDPRACTICEGUIDELINE20106射频在肝癌等肿瘤治疗中的地位射频在肝癌等肿瘤治疗中的地位 近年以近年以射频消融射频消融为代表的局部治疗发展迅猛，治疗小肝癌疗为代表的局部治疗发展迅猛，治疗小肝癌疗效不断提高，接近手术切除。效不断提高，接近手术切除。RFARFA已经成为继手术切除和已经成为继手术切除和肝移植术之后小肝癌的肝移植术之后小肝癌的第三种根治性治疗手段第三种根治性治疗手段，手术切除，手术切除的首选地位受到了挑战。的首选地位受到了挑战。 陈敏山陈敏山射频消融在小肝癌治疗中的地位射频消融在小肝癌治疗中的地位Chinese Journal of Cancer,2007,26(5)Chinese Journal of Cancer,2007,26(5)7专家评述专家评述n高温使肿瘤组织凝固性坏死，最终形成液化灶或纤维化，起到原位灭活肿瘤组织作用；n高温使肿瘤周围血管闭塞并形成一个反应带，使之不能向肿瘤组织供血，可防止肿瘤复发或转移；n高温灭活的肿瘤组织由于细胞免疫表形的变化而具有瘤苗作用，从而发生特殊的抗肿瘤免疫作用。8射频治疗肿瘤射频治疗肿瘤机制机制n微创，最大限度地保留靶器官功能；n并发症少、恢复快、患者易接受；n疗效确切，可重复治疗；n适应症广；n操作简单，定位、温控可靠。9射频肿瘤消融治疗射频肿瘤消融治疗特点特点n原位灭活：微创根治肿瘤n综合治疗：联合手术、TACE、粒子植入、 化疗n姑息治疗：缓解症状，提高生存质量10 提高肿瘤局部控制率提高肿瘤局部控制率射频在临床中的应用射频在临床中的应用内容提要内容提要1.射频及其在肿瘤临床中的应用；2.Endo-HPB是什么及其操作方法；3.Endo-HPB主要作用及其临床应用；4.Endo-HPB临床效果；11EndoEndo- -HPBHPB射频消融导管射频消融导管一次性使用一次性使用0.9m0.9m或或1.8m 1.8m 长长8Fr (2.6mm) 8Fr (2.6mm) .035inch .035inch 英寸导丝英寸导丝3.2mm 3.2mm 内镜工作管道内镜工作管道双极、不锈钢双环的距离间隔为双极、不锈钢双环的距离间隔为8 8mmmm加热区域：加热区域： 25mm +/-3mm25mm +/-3mm12全球专利及欧美认证全球专利及欧美认证-HPB-HPB由英国帝国理工大学著名外科专家由英国帝国理工大学著名外科专家 Nagy HabibNagy Habib教授发明教授发明20072007年获得全球专利年获得全球专利( (专利号专利号WO2007135437)WO2007135437)20092009年获欧盟年获欧盟CECE及美国及美国FDAFDA认证认证20122012年获中国年获中国SFDASFDA认证认证13Fig. 4 The specimens were resected for the evaluation of microscopic findingsFig. 5 Ablation by lower power and short time (5 W and 60 s) showed insufficient ablationEndoHPBEndoHPB消融范围消融范围2.52.5* *1cm(1cm(直径直径) )14Takao Itoi et al. Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex-vivo pig liver。 J Hepatobiliary Pancreat SciDOI 10.1007/s00534-011-0465-7 Takao Itoi et al. Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex-vivo pig liver。 J Hepatobiliary Pancreat SciDOI 10.1007/s00534-011-0465-7 HPBHPB消融范围与时间、功率间的关系消融范围与时间、功率间的关系15Ablationpower (W)Ablationtime (s)Lengtha (mm)Lengthb (mm)5604.3 0.611.0 1.05905.3 0.613.0 1.751207.3 0.618.0 1.010608.0 1.020.3 0.610908.3 1.221.3 1.61012010.3 0.627.7 1.615608.3 0.623.7 1.2159010.0 1.026.7 0.61512010.3 0.627.7 0.620609.3 0.629.0 1.0209011.3 1.229.0 1.72012011.3 1.229.0 1.0 经内镜逆行胆胰管造影经内镜逆行胆胰管造影(ERCP) (ERCP) 或经皮肝穿刺胆道或经皮肝穿刺胆道造影造影 (PTC)(PTC)1.1.插进导丝并通过乏特壶腹插进导丝并通过乏特壶腹 2.2.在进行在进行X X光影像判断和评估胆道梗阻的长度后，将光影像判断和评估胆道梗阻的长度后，将EndoHPBEndoHPB插进至肿瘤的上部。插进至肿瘤的上部。3.3.将功率设置为将功率设置为8-8-1010瓦特，消融瓦特，消融9090秒秒-2-2分钟。消融组织长度分钟。消融组织长度为为 2.5cm2.5cm，宽度为，宽度为0.5cm0.5cm4.4.可以根据肿瘤的长度重复一次或两次消融可以根据肿瘤的长度重复一次或两次消融5.5.在将射频电极移走后，放入金属支架在将射频电极移走后，放入金属支架操作方法操作方法16经皮经肝胆管内射频消融经皮经肝胆管内射频消融1718Insertion of a 0.0035” guidewire经经ERCPERCP胆管内射频消融胆管内射频消融1819Insertion of the Habib EndoHPB into bile ductInsertion of the Habib EndoHPB into bile duct经经ERCPERCP胆管内射频消融胆管内射频消融1920Insertion of the Habib EndoHPB into bile duct经经ERCPERCP胆管内射频消融胆管内射频消融2021Insertion of the Habib EndoHPB into bile duct经经ERCPERCP胆管内射频消融胆管内射频消融21222 electrodes separated for total ablation 经经ERCPERCP胆管内射频消融胆管内射频消融22233 or 4 application times according to stricture经经ERCPERCP胆管内射频消融胆管内射频消融23内容提要内容提要1.射频及其在肿瘤临床中的应用；2.Endo-HPB是什么及其操作方法；3.Endo-HPB主要作用及其临床应用；4.Endo-HPB临床效果；24EndoHPBEndoHPB主要作用及临床应用主要作用及临床应用临床应用：临床应用：解决目前管道支架容解决目前管道支架容易出现的再闭塞问题易出现的再闭塞问题放置支架前对肿瘤进放置支架前对肿瘤进行射频消融行射频消融对胆道肿瘤进行射频对胆道肿瘤进行射频消融后不放置支架消融后不放置支架25主要作用：主要作用：通过射频直接杀死胆管内通过射频直接杀死胆管内肿瘤细胞肿瘤细胞可有效延长支架畅通期可有效延长支架畅通期延长患者生存时间延长患者生存时间改善患者生存质量改善患者生存质量PTCDPTCD造影明确梗阻部位造影明确梗阻部位肿瘤腔内导管射频消融肿瘤腔内导管射频消融胆道支架植入胆道支架植入完成消融减完成消融减瘤，达到解瘤，达到解除梗阻、改除梗阻、改善患者生存善患者生存质量目的。质量目的。26HPBHPB消融减瘤，解除梗阻消融减瘤，解除梗阻胆道支架放置前射频消融术后即刻效果胆道支架放置前射频消融术后即刻效果-PTCD-PTCD27胆道支架放置前射频消融术后即刻效果胆道支架放置前射频消融术后即刻效果-ERCP-ERCP胆管内射频消融前后胆管内射频消融前后胆管内射频消融前后胆管内射频消融前后 (Reddy)(Reddy)(Reddy)(Reddy)28胰腺癌放疗术后胰腺癌放疗术后3 3月，月，支架阻塞获得再通支架阻塞获得再通29胰腺癌支架阻塞再通处理胰腺癌支架阻塞再通处理30胰腺癌支架置入前射频消融胰腺癌支架置入前射频消融射频电极被插进胆总管在进行射频消融后，金属支架被放进右肝胆管31胰头腺癌射频消融胰头腺癌射频消融患有胰腺腺癌的病人，胆管造影显示胆总管下段狭窄射频电极穿过狭窄处胰头腺癌射频消融胰头腺癌射频消融32壶腹腺癌射频消融，电极穿过肿瘤壶腹腺癌射频消融，电极穿过肿瘤壶腹腺癌射频消融壶腹腺癌射频消融3334支架内阻塞射频消融支架内阻塞射频消融Metal stent金属支架金属支架Endoablator in situ射频导管定位射频导管定位Ablation with 10W 2min x 2消融：消融：10瓦特，瓦特， 2分钟分钟 2次次Ablation with 30W 3min 消融：消融：30瓦特，瓦特，3分钟分钟支架内阻塞射频消融支架内阻塞射频消融-PTCD-PTCD3536支架内阻塞射频消融支架内阻塞射频消融-ERCP-ERCP37支架内阻塞射频消融支架内阻塞射频消融-ERCP-ERCP内容提要内容提要1.射频及其在肿瘤临床中的应用；2.Endo-HPB是什么及其操作方法；3.Endo-HPB主要作用及其临床应用；4.Endo-HPB临床效果；38胆道支架阻塞后射频消融临床研究胆道支架阻塞后射频消融临床研究39Table 1 Patient characteristicsTotal number of patients9Age (median), yr72 (3978)Male:female ratio7:2Cholangiocarcinoma6 Bismuth type I1 Bismuth type II1 Bismuth type IIIA1 Bismuth type IV 3Pancreatic adenocarcinoma 2Metastatic disease1M. Pai et al.: Intraductal Radiofrequency Ablation for Clearance of Occluded Metal Stent。Cardiovasc Intervent Radiol DOI 10.1007/s00270-013-0688-x，胆道支架阻塞后射频消融临床研究胆道支架阻塞后射频消融临床研究40Table 2 Procedure detailsLength of stricture (cm)a5.2 1.6No. of ablations2 (13)Duration of ablation (min)6 (220)Ablation energy (watts)10 (1020)Preablation diameter (mm)1.6 (04)Postablation diameter (mm)8 (310)Preablation bilirubin (lmol/L)109 43Postablation bilirubin (lmol/L)60 27M. Pai et al.: Intraductal Radiofrequency Ablation for Clearance of Occluded Metal Stent。Cardiovasc Intervent Radiol DOI 10.1007/s00270-013-0688-x，胆道支架阻塞后射频消融临床研究胆道支架阻塞后射频消融临床研究41M. Pai et al.: Intraductal Radiofrequency Ablation for Clearance of Occluded Metal Stent.Cardiovasc Intervent Radiol DOI 10.1007/s00270-013-0688-x，Fig. 2 A. Preablation holangiogram shows stent blockage. B. Cholangiogram shows radiofrequency ablation with the HabibTM HPB inside the blocked stent. C, D Postablation cholangiogram shows patent stent经皮胆道射频消融治疗的安全性及临床疗效研究经皮胆道射频消融治疗的安全性及临床疗效研究42Table 1 Patient characteristics Total number of patients39 Age (median), yr67.5 (4287) Male:female ratio22:17 Cholangiocarcinoma17 Bismuth type I5 Bismuth type II1 Bismuth type IIIA4 Bismuth type IV 7 Pancreatic adenocarcinoma 11 Gallbladder adenocarcinoma4 Metastatic disease5 epatocellular carcinoma1 Ampullary adenocarcinoma1Malkhaz Mizandari Madhava Pai et al. Percutaneous Intraductal Radiofrequency Ablation is a Safe Treatment for Malignant Biliary bstruction: Feasibility and Early Results. Cardiovasc Intervent Radiol DOI 10.1007/s00270-012-0529-3经皮胆道射频消融治疗的安全性及临床疗效研究经皮胆道射频消融治疗的安全性及临床疗效研究43Table 2 Procedure details Length of stricture (cm)a 3.39 1.06 No. of ablations 1 (14) Duration of ablation (min) 2 (220) Ablation energy (watts) 10 (815) Preablation diameter (mm) 1 (02) Postablation diameter (mm) 7 (310)Malkhaz Mizandari Madhava Pai et al. Percutaneous Intraductal Radiofrequency Ablation is a Safe Treatment for Malignant Biliary bstruction: Feasibility and Early Results. Cardiovasc Intervent Radiol DOI 10.1007/s00270-012-0529-3经皮胆道射频消融治疗的安全性及临床疗效研究经皮胆道射频消融治疗的安全性及临床疗效研究44ParametersPreablationPostablation(day 2)Normal rangeBilirubin (lmol/L)129 6152 32a021ALP (IU/L)1,154 8641,032 79730130ALT (IU/L)108 6578 4240GGT (IU/L)755 739760 63255LDH (IU/L)384 89313 520250AST (IU/L)96 6081 3940Malkhaz Mizandari Madhava Pai et al. Percutaneous Intraductal Radiofrequency Ablation is a Safe Treatment for Malignant Biliary bstruction: Feasibility and Early Results. Cardiovasc Intervent Radiol DOI 10.1007/s00270-012-0529-3ERCPERCP射频消融治疗恶性胆道梗阻治疗的安全性射频消融治疗恶性胆道梗阻治疗的安全性45TABLE 1. Demographics (N22)Sex: male11Age, y, mean (range)70 (56-84)Pancreatic/cholangiocarcinoma, no. 16/6Metastatic, no. 10Locally advanced, no. 17Metastatic and locally advanced, no. 7Hilar strictures, no. 6Plastic stent before SEMS, no. 16Sepsis at RFA ERCP, no. 7Bilirubin, mol/L, median (range)26 (4-286)Karnofsky score, median (range)55 (40-100)Alan W. Steel, MD, MRCP, Aymer J. Postgate，etal Endoscopically applied radiofrequency ablation appears to be safe inthe treatment of malignant biliary obstruction；Volume 73, No. 1 : 2011 GASTROINTESTINAL ENDOSCOPY，149-153ERCPERCP射频消融治疗恶性胆道梗阻治疗的安全性射频消融治疗恶性胆道梗阻治疗的安全性46TABLE 2. Radiofrequency ablation procedure details (N21)Procedure time, min, mean (range)43 (22-68)Fluoroscopic screening time, min, median (range)5 (3-36)No. of applications, median (range)2 (1-4)Length of stricture, mm, mean (range)37 (20-60)Stricture diameter before RFA, mm, median (range)0 (0-1)Stricture diameter after RFA, mm, median (range)4 (3-6)After ERCP day stay, d, median (range)1 (1-24)Median stent patency at day 90 offinal subject, d, median (range)114 (0-498)Alan W. Steel, MD, MRCP, Aymer J. Postgate，etal Endoscopically applied radiofrequency ablation appears to be safe inthe treatment of malignant biliary obstruction；Volume 73, No. 1 : 2011 GASTROINTESTINAL ENDOSCOPY，149-153胆道恶性梗阻内镜下射频消融胆道恶性梗阻内镜下射频消融-国外回顾性研究国外回顾性研究47Biliary tract cancer (Klatskin tumor, distal CCa, gallbladder carcinoma)Pancreatic cancerCentral HCC, mixed HCC/CCa, mCRCTotalNo. of patients 51 4 3 58Gender (m:f) 27:24 0:4 3:0 31:27Age, years (range) 76 (2888) 62 (5582) 70 (6371) 75 (2888)Co-therapies CHT 20, S 3, RT 2, PDT 2 CHT 3 CHT 1, S 1, TACE 1 CHT 24, S 4, RT 2,PDT 2, TACE 1RFA sessions 1 *= 37, 2 * = 6, 3 * = 2, 4 * = 4, 5 * =1 1 *=4 1 * =3 1*=44,2*=6,3 *= 2, 4*= 4,5* = 1Werner Dolak Florian Schreiber et al.Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications；Surg Endosc DOI 10.1007/s00464-013-3232-9CCa cholangiocarcinoma, CHT chemotherapy, CI confidence interval, HCC hepatocellular carcinoma, mCRC metastatic colorectal cancer, PDT photodynamic therapy, RFA radiofrequency ablation, RT radiotherapy, S surgery, TACE transarterial chemoembolization胆道恶性梗阻内镜下射频消融胆道恶性梗阻内镜下射频消融-国外回顾性研究国外回顾性研究48Biliary tract cancer (Klatskin tumor, distal CCa, gallbladder carcinoma)PancreaticcancerCentral HCC, mixed HCC/CCa, mCRCTotalNo. of patients 51 4 3 58InterventionalcomplicationsPartial liver infarction None None (as listed)Adverse events within 30 days post RFACholangitis 5, hemobilia 2, cholangiosepsis 2, hepatic coma 1, left bundle branch block1Gallbladderempyema 1Hemobilia 1 (as listed)Survival after first RFA/initial diagnosis (95% CI)10.9/19.1 m5.0/8.8 m10.5/98.4 m 10.6 m (6.914.4)/17.9m (10.325.6)Werner Dolak Florian Schreiber et al.Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications；Surg Endosc DOI 10.1007/s00464-013-3232-9CCa cholangiocarcinoma, CHT chemotherapy, CI confidence interval, HCC hepatocellular carcinoma, mCRC metastatic colorectal cancer, PDT photodynamic therapy, RFA radiofrequency ablation, RT radiotherapy, S surgery, TACE transarterial chemoembolization49射频消融延长胰腺癌患者生存期射频消融延长胰腺癌患者生存期50射频消融延长胰腺癌患者生存期射频消融延长胰腺癌患者生存期