RSS-Feed abonnieren
DOI: 10.1055/s-0043-124870
Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial
TRIAL REGISTRATION: Single-center, randomized, prospective trial NCT02592538 at clinicaltrials.govPublikationsverlauf
submitted 14. August 2017
accepted after revision 26. November 2017
Publikationsdatum:
17. Januar 2018 (online)
Abstract
Background Endoscopic placement of biliary stents to relieve jaundice is the main palliative treatment for unresectable extrahepatic cholangiocarcinoma. Endoscopic biliary radiofrequency ablation (RFA) has been reported to prolong stent patency, which may be beneficial in improving patient survival. However, available evidence is still insufficient, as most reported studies are retrospective case series. The aim of this study was to explore the clinical effect and safety of RFA in patients with unresectable extrahepatic cholangiocarcinoma.
Methods 65 patients with unresectable extrahepatic cholangiocarcinoma, except Bismuth type III and IV hilar cholangiocarcinoma, were enrolled and randomly underwent either RFA combined with biliary stenting (RFA + stent group; n = 32) or biliary stent only (stent-only group; n = 33). Overall survival time, stent patency period, and postoperative adverse events were recorded.
Results In the 21-month follow-up period, the overall mean survival time was significantly longer in the RFA + stent group than in the stent-only group (13.2 ± 0.6 vs. 8.3 ± 0.5 months; P < 0.001). The mean stent patency period of the RFA + stent group was also significantly longer than that of the stent-only group (6.8 vs. 3.4 months; P = 0.02). There was no significant difference in the incidence of postoperative adverse events between the two groups (6.3 % [2/32] vs. 9.1 % [3/33]; P = 0.67).
Conclusion Endoscopic RFA combined with stenting can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extrahepatic cholangiocarcinoma patient, except Bismuth type III and IV hilar cholangiocarcinoma. This approach can be considered as a safe and effective palliative treatment for these patients.
* These authors contributed equally to this work.
-
References
- 1 Charbel H, Al-Kawas FH. Cholangiocarcinoma: epidemiology, risk factors, pathogenesis, and diagnosis. Curr Gastroenterol Rep 2011; 13: 182-187
- 2 Razumilava N, Gores GJ. Classification, diagnosis, and management of cholangiocarcinoma. Clin Gastroenterol Hepatol 2013; 11: 13-21
- 3 Blechacz B, Komuta M, Roskams T. et al. Clinical diagnosis and staging of cholangiocarcinoma. Nat Rev Gastroenterol Hepatol 2011; 8: 512-522
- 4 Skipworth JR, Olde DSW, Imber C. et al. Review article: surgical, neo-adjuvant and adjuvant management strategies in biliary tract cancer. Aliment Pharmacol Ther 2011; 34: 1063-1078
- 5 Zografos GN, Farfaras A, Zagouri F. et al. Cholangiocarcinoma: principles and current trends. Hepatobiliary Pancreat Dis Int 2011; 10: 10-20
- 6 Esnaola NF, Meyer JE, Karachristos A. et al. Evaluation and management of intrahepatic and extrahepatic cholangiocarcinoma. Cancer 2016; 122: 1349-1369
- 7 Monkemuller K, Popa D, Wilcox CM. Endoscopic treatment options for cholangiocarcinomas. Expert Rev Anticancer Ther 2014; 14: 407-418
- 8 Groot KB, Fong Y. Outcomes in biliary malignancy. J Surg Oncol 2014; 110: 585-591
- 9 Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet 2014; 383: 2168-2179
- 10 Parodi A, Fisher D, Giovannini M. et al. Endoscopic management of hilar cholangiocarcinoma. Nat Rev Gastroenterol Hepatol 2012; 9: 105-112
- 11 Shariff MI, Khan SA, Westaby D. The palliation of cholangiocarcinoma. Curr Opin Support Palliat Care 2013; 7: 168-174
- 12 Feng Q, Chi Y, Liu Y. et al. Efficacy and safety of percutaneous radiofrequency ablation versus surgical resection for small hepatocellular carcinoma: a meta-analysis of 23 studies. J Cancer Res Clin Oncol 2015; 141: 1-9
- 13 Wadsworth CA, Westaby D, Khan SA. Endoscopic radiofrequency ablation for cholangiocarcinoma. Curr Opin Gastroenterol 2013; 29: 305-311
- 14 Tanguturi SK, Wo JY, Zhu AX. et al. Radiation therapy for liver tumors: ready for inclusion in guidelines. Oncologist 2014; 19: 868-879
- 15 Han K, Ko HK, Kim KW. et al. Radiofrequency ablation in the treatment of unresectable intrahepatic cholangiocarcinoma: systematic review and meta-analysis. J Vasc Interv Radiol 2015; 26: 943-948
- 16 Steel AW, Postgate AJ, Khorsandi S. et al. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc 2011; 73: 149-153
- 17 Laquiere A, Boustiere C, Leblanc S. et al. Safety and feasibility of endoscopic biliary radiofrequency ablation treatment of extrahepatic cholangiocarcinoma. Surg Endosc 2016; 30: 1242-1248
- 18 Tal AO, Vermehren J, Friedrich-Rust M. et al. Intraductal endoscopic radiofrequency ablation for the treatment of hilar non-resectable malignant bile duct obstruction. World J Gastrointest Endosc 2014; 6: 13-19
- 19 Zacharoulis D, Lazoura O, Sioka E. et al. Habib EndoHPB: a novel endobiliary radiofrequency ablation device. An experimental study. J Invest Surg 2013; 26: 6-10
- 20 Benson AB, Abrams TA, Ben-Josef E. et al. NCCN clinical practice guidelines in oncology: hepatobiliary cancers. J Natl Compr Canc Netw 2009; 7: 350-391
- 21 Yang J, Shen H, Jin H. et al. Treatment of unresectable extrahepatic cholangiocarcinoma using hematoporphyrin photodynamic therapy: a prospective study. Photodiagnosis Photodyn Ther 2016; 16: 110-118
- 22 Cotton PB, Garrow DA, Gallagher J. et al. Risk factors for complications after ERCP: a multivariate analysis of 11,497 procedures over 12 years. Gastrointest Endosc 2009; 70: 80-88
- 23 Ortner ME, Caca K, Berr F. et al. Successful photodynamic therapy for nonresectable cholangiocarcinoma: a randomized prospective study. Gastroenterology 2003; 125: 1355-1363
- 24 Rustagi T, Jamidar PA. Intraductal radiofrequency ablation for management of malignant biliary obstruction. Dig Dis Sci 2014; 59: 2635-2641
- 25 Sharaiha RZ, Sethi A, Weaver KR. et al. Impact of radiofrequency ablation on malignant biliary strictures: results of a collaborative registry. Dig Dis Sci 2015; 60: 2164-2169
- 26 Figueroa-Barojas P, Bakhru MR, Habib NA. et al. Safety and efficacy of radiofrequency ablation in the management of unresectable bile duct and pancreatic cancer: a novel palliation technique. J Oncol 2013; 2013: 910897
- 27 Alis H, Sengoz C, Gonenc M. et al. Endobiliary radiofrequency ablation for malignant biliary obstruction. Hepatobiliary Pancreat Dis Int 2013; 12: 423-427
- 28 Dolak W, Schreiber F, Schwaighofer H. et al. Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications. Surg Endosc 2014; 28: 854-860
- 29 Sharaiha RZ, Natov N, Glockenberg KS. et al. Comparison of metal stenting with radiofrequency ablation versus stenting alone for treating malignant biliary strictures: is there an added benefit?. Dig Dis Sci 2014; 59: 3099-3102
- 30 Kallis Y, Phillips N, Steel A. et al. Analysis of endoscopic radiofrequency ablation of biliary malignant strictures in pancreatic cancer suggests potential survival benefit. Dig Dis Sci 2015; 60: 3449-3455
- 31 Uppal DS, Wang AY. Advances in endoscopic retrograde cholangiopancreatography for the treatment of cholangiocarcinoma. World J Gastrointest Endosc 2015; 7: 675-687
- 32 Zhou C, Wei B, Gao K. et al. Biliary tract perforation following percutaneous endobiliary radiofrequency ablation: a report of two cases. Oncol Lett 2016; 11: 3813-3816
- 33 Itoi T, Isayama H, Sofuni A. et al. Evaluation of effects of a novel endoscopically applied radiofrequency ablation biliary catheter using an ex-vivo pig liver. J Hepatobiliary Pancreat Sci 2012; 19: 543-547
- 34 Luo H, Zhao L, Leung J. et al. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet 2016; 387: 2293-2301
- 35 Wang Y, Cui W, Fan W. et al. Percutaneous intraductal radiofrequency ablation in the management of unresectable Bismuth types III and IV hilar cholangiocarcinoma. Oncotarget 2016; 7: 53911-53920