Safety and Efficacy of Endobiliary Radio-Frequency Ablation in Hilar Cholangiocarcinoma
Abstract
Introduction:
Hilar Cholangiocarcinoma (hCAA) is often incurable at diagnosis and palliative treatment is the only option for most patients. Endoscopic placement of biliary stents to facilitate bile flow forms the cornerstone of palliative therapy. Tumour ingrowth with blockage of stent continues to be a major problem. Endo- Biliary Radio Frequency Ablation (EBRA) has emerged as an adjunct to existing treatment options by potentially prolonging stent patency and survival. However the safety and efficacy of EBRA is still an area that merits further study.
Methods :
The study was conducted at a high volume tertiary care centre from January 2017 to December 2019 where consecutive patients of hCCA requiring endoscopic palliation were included. EBRA was performed using the ELRATM (Endo Luminal Radiofrequency Ablation) electrode from Taewoong Medical (South Korea) during the ERC, followed by the placement of a Self-expanding metallic stent (SEMS) as per protocol (Group 1). Patients who did not consent to the EBRA were treated with SEMS alone and served as controls (Group 2). The primary outcome was overall survival; while secondary outcomes studied were need for repeat interventions and procedure related adverse events.
Results :
A total of 49 patients were included (mean age 66.65±12.96 years, M:F=0.8). 22 patients underwent EBRA (Group 1); and 27 patients underwent SEMS placement alone (Group 2). The baseline characteristics (age, gender, bismuth staging of hCCA and post drainage palliative chemotherapy) were similar in both groups. The median survival for group 1 was 282 days and for group 2 was 180 days (p=0.008). Post procedure cholangitis was noted in 7/22 patients (31.8%) in Group 1 and 8/27 patients (30.7%) in group 2. Four patients (17.3%) in group 1 required re-stenting within 6 months while 8 patients (30.7%) required re-stenting in group 2.
Conclusions:
Patients who underwent EBRA were found to have a significant survival advantage as compared to standard treatment options. EBRA was found to be technically feasible, safe and can be a useful adjunct to endoscopic palliation in patients with hCCA.
Keywords
References
REFERENCES
Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Dicker D, Pain A, Hamavid H, Moradi-Lakeh M, MacIntyre MF, Allen C, Hansen G, Woodbrook R, Wolfe C, Hamadeh RR, Moore A, Werdecker A, Gessner BD, Te Ao B, McMahon B, Karimkhani C, Yu C, Cooke GS, Schwebel DC, Carpenter DO, Pereira DM, Nash D, Kazi DS, De Leo D, Plass D, Ukwaja KN, Thurston GD, Yun Jin K, Simard EP, Mills E, Park E-K, Catalá-López F, deVeber G, Gotay C, Khan G, Hosgood HD, Santos IS, Leasher JL, Singh J, Leigh J, Jonas JB, Jonas J, Sanabria J, Beardsley J, Jacobsen KH, Takahashi K, Franklin RC, Ronfani L, Montico M, Naldi L, Tonelli M, Geleijnse J, Petzold M, Shrime MG, Younis M, Yonemoto N, Breitborde N, Yip P, Pourmalek F, Lotufo PA, Esteghamati A, Hankey GJ, Ali R, Lunevicius R, Malekzadeh R, Dellavalle R, Weintraub R, Lucas R, Hay R, Rojas-Rueda D, Westerman R, Sepanlou SG, Nolte S, Patten S, Weichenthal S, Abera SF, Fereshtehnejad S-M, Shiue I, Driscoll T, Vasankari T, Alsharif U, Rahimi-Movaghar V, Vlassov VV, Marcenes WS, Mekonnen W, Melaku YA, Yano Y, Artaman A, Campos I, MacLachlan J, Mueller U, Kim D, Trillini M, Eshrati B, Williams HC, Shibuya K, Dandona R, et al. The Global Burden of Cancer 2013. JAMA Oncol 2015; 1: 505–527. [PMID: 26181261 DOI: 10.1001/jamaoncol.2015.0735]
Banales JM, Cardinale V, Carpino G, Marzioni M, Andersen JB, Invernizzi P, Lind GE, Folseraas T, Forbes SJ, Fouassier L, Geier A, Calvisi DF, Mertens JC, Trauner M, Benedetti A, Maroni L, Vaquero J, Macias RIR, Raggi C, Perugorria MJ, Gaudio E, Boberg KM, Marin JJG, Alvaro D. Expert consensus document: Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nat Rev Gastroenterol Hepatol 2016; 13: 261–280. [PMID: 27095655 DOI: 10.1038/nrgastro.2016.51]
Razumilava N, Gores GJ. Cholangiocarcinoma. Lancet Lond Engl 2014; 383: 2168–2179. [PMID: 24581682 DOI: 10.1016/S0140-6736(13)61903-0]
Khan SA, Emadossadaty S, Ladep NG, Thomas HC, Elliott P, Taylor-Robinson SD, Toledano MB. Rising trends in cholangiocarcinoma: is the ICD classification system misleading us? J Hepatol 2012; 56: 848–854. [PMID: 22173164 DOI: 10.1016/j.jhep.2011.11.015]
Gerges C, Schumacher B, Terheggen G, Neuhaus H. Expandable metal stents for malignant hilar biliary obstruction. Gastrointest Endosc Clin N Am 2011; 21: 481–497, ix. [PMID: 21684466 DOI: 10.1016/j.giec.2011.04.004]
Larghi A, Tringali A, Lecca PG, Giordano M, Costamagna G. Management of hilar biliary strictures. Am J Gastroenterol 2008; 103: 458–473. [PMID: 18028506 DOI: 10.1111/j.1572-0241.2007.01645.x]
Roughneen PT, Gouma DJ, Kulkarni AD, Fanslow WF, Rowlands BJ. Impaired specific cell-mediated immunity in experimental biliary obstruction and its reversibility by internal biliary drainage. J Surg Res 1986; 41: 113–125. [PMID: 3762122 DOI: 10.1016/0022-4804(86)90016-8]
Gouma DJ, Roughneen PT, Kumar S, Moody FG, Rowlands BJ. Changes in nutritional status associated with obstructive jaundice and biliary drainage in rats. Am J Clin Nutr 1986; 44: 362–369. [PMID: 3751957 DOI: 10.1093/ajcn/44.3.362]
Isayama H, Komatsu Y, Tsujino T, Sasahira N, Hirano K, Toda N, Nakai Y, Yamamoto N, Tada M, Yoshida H, Shiratori Y, Kawabe T, Omata M. A prospective randomised study of “covered” versus “uncovered” diamond stents for the management of distal malignant biliary obstruction. Gut 2004; 53: 729–734. [PMID: 15082593 DOI: 10.1136/gut.2003.018945]
Kaassis M, Boyer J, Dumas R, Ponchon T, Coumaros D, Delcenserie R, Canard J-M, Fritsch J, Rey J-F, Burtin P. Plastic or metal stents for malignant stricture of the common bile duct? Results of a randomized prospective study. Gastrointest Endosc 2003; 57: 178–182. [PMID: 12556780 DOI: 10.1067/mge.2003.66]
Almadi MA, Barkun A, Martel M. Plastic vs. Self-Expandable Metal Stents for Palliation in Malignant Biliary Obstruction: A Series of Meta-Analyses. Am J Gastroenterol 2017; 112: 260–273. [PMID: 27845340 DOI: 10.1038/ajg.2016.512]
Faigel DO. Preventing biliary stent occlusion. Gastrointest Endosc 2000; 51: 104–107. [PMID: 10625815 DOI: 10.1016/s0016-5107(00)70403-2]
Steel AW, Postgate AJ, Khorsandi S, Nicholls J, Jiao L, Vlavianos P, Habib N, Westaby D. Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction. Gastrointest Endosc 2011; 73: 149–153. [PMID: 21184881 DOI: 10.1016/j.gie.2010.09.031]
Mansour JC, Aloia TA, Crane CH, Heimbach JK, Nagino M, Vauthey J-N. Hilar Cholangiocarcinoma: expert consensus statement. HPB 2015; 17: 691–699. [DOI: 10.1111/hpb.12450]
ASGE Standards of Practice Committee, Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc 2017; 85: 32–47. [PMID: 27546389 DOI: 10.1016/j.gie.2016.06.051]
Bertuccio P, Malvezzi M, Carioli G, Hashim D, Boffetta P, El-Serag HB, La Vecchia C, Negri E. Global trends in mortality from intrahepatic and extrahepatic cholangiocarcinoma. J Hepatol 2019; 71: 104–114. [PMID: 30910538 DOI: 10.1016/j.jhep.2019.03.013]
Banales JM, Marin JJG, Lamarca A, Rodrigues PM, Khan SA, Roberts LR, Cardinale V, Carpino G, Andersen JB, Braconi C, Calvisi DF, Perugorria MJ, Fabris L, Boulter L, Macias RIR, Gaudio E, Alvaro D, Gradilone SA, Strazzabosco M, Marzioni M, Coulouarn C, Fouassier L, Raggi C, Invernizzi P, Mertens JC, Moncsek A, Rizvi S, Heimbach J, Koerkamp BG, Bruix J, Forner A, Bridgewater J, Valle JW, Gores GJ. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol 2020; 17: 557–588. [DOI: 10.1038/s41575-020-0310-z]
Petrick JL, Yang B, Altekruse SF, Dyke ALV, Koshiol J, Graubard BI, McGlynn KA. Risk factors for intrahepatic and extrahepatic cholangiocarcinoma in the United States: A population-based study in SEER-Medicare. PLOS ONE 2017; 12: e0186643. [DOI: 10.1371/journal.pone.0186643]
Tringali A, Boškoski I, Costamagna G. Endoscopic Stenting in Hilar Cholangiocarcinoma: When, How, and How Much to Drain? Gastroenterol Res Pract 2019; 2019: 5161350. [PMID: 31781190 DOI: 10.1155/2019/5161350]
Raijman I. Biliary and pancreatic stents. Gastrointest Endosc Clin N Am 2003; 13: 561–592, vii–viii. [PMID: 14986787 DOI: 10.1016/s1052-5157(03)00069-2]
Larghi A, Rimbaș M, Tringali A, Boškoski I, Rizzatti G, Costamagna G. Endoscopic radiofrequency biliary ablation treatment: A comprehensive review. Dig Endosc Off J Jpn Gastroenterol Endosc Soc 2019; 31: 245–255. [PMID: 30444547 DOI: 10.1111/den.13298]
Laleman W, van der Merwe S, Verbeke L, Vanbeckevoort D, Aerts R, Prenen H, Van Cutsem E, Verslype C. A new intraductal radiofrequency ablation device for inoperable biliopancreatic tumors complicated by obstructive jaundice: the IGNITE-1 study. Endoscopy 2017; 49: 977–982. [PMID: 28732391 DOI: 10.1055/s-0043-113559]
Tang Z, Yang Y, Meng W, Li X. Best option for preoperative biliary drainage in Klatskin tumor: A systematic review and meta-analysis. Medicine (Baltimore) 2017; 96: e8372. [DOI: 10.1097/MD.0000000000008372]
Coelen RJS, Roos E, Wiggers JK, Besselink MG, Buis CI, Busch ORC, Dejong CHC, Delden OM van, Eijck CHJ van, Fockens P, Gouma DJ, Koerkamp BG, Haan MW de, Hooft JE van, IJzermans JNM, Kater GM, Koornstra JJ, Lienden KP van, Moelker A, Damink SWMO, Poley J-W, Porte RJ, Ridder RJ de, Verheij J, Woerden V van, Rauws EAJ, Dijkgraaf MGW, Gulik TM van. Endoscopic versus percutaneous biliary drainage in patients with resectable perihilar cholangiocarcinoma: a multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol 2018; 3: 681–690. [PMID: 30122355 DOI: 10.1016/S2468-1253(18)30234-6]
Tal AO, Vermehren J, Friedrich-Rust M, Bojunga J, Sarrazin C, Zeuzem S, Trojan J, Albert JG. Intraductal endoscopic radiofrequency ablation for the treatment of hilar non-resectable malignant bile duct obstruction. World J Gastrointest Endosc 2014; 6: 13–19. [PMID: 24527176 DOI: 10.4253/wjge.v6.i1.13]
Sharaiha RZ, Natov N, Glockenberg KS, Widmer J, Gaidhane M, Kahaleh M. 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. [PMID: 25033929 DOI: 10.1007/s10620-014-3264-6]
Sofi AA, Khan MA, Das A, Sachdev M, Khuder S, Nawras A, Lee W. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc 2018; 87: 944-951.e1. [PMID: 29108980 DOI: 10.1016/j.gie.2017.10.029]
Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy 2018; 50: 751–760. [PMID: 29342492 DOI: 10.1055/s-0043-124870]
Schueller G, Kettenbach J, Sedivy R, Stift A, Friedl J, Gnant M, Lammer J. Heat shock protein expression induced by percutaneous radiofrequency ablation of hepatocellular carcinoma in vivo. Int J Oncol 2004; 24: 609–613.
Sawas T, Al Halabi S, Parsi MA, Vargo JJ. Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis. Gastrointest Endosc 2015; 82: 256-267.e7. [PMID: 25982849 DOI: 10.1016/j.gie.2015.03.1980]
Puli SR, Kalva N, Pamulaparthy SR, Bechtold ML, Cashman MD, Volmar F-H, Dhillon S, Shekleton MF, Estes NC, Carr-Locke D. Bilateral and unilateral stenting for malignant hilar obstruction: a systematic review and meta-analysis. Indian J Gastroenterol Off J Indian Soc Gastroenterol 2013; 32: 355–362. [PMID: 24214663 DOI: 10.1007/s12664-013-0413-3]
Hong W, Sun X, Zhu Q. Endoscopic stenting for malignant hilar biliary obstruction: should it be metal or plastic and unilateral or bilateral? Eur J Gastroenterol Hepatol 2013; 25: 1105–1112. [PMID: 23542449 DOI: 10.1097/MEG.0b013e328360b9ec]
Lee TH, Kim TH, Moon JH, Lee SH, Choi HJ, Hwangbo Y, Hyun JJ, Choi J-H, Jeong S, Kim JH, Park DH, Han J-H, Park S-H. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc 2017; 86: 817–827. [PMID: 28479493 DOI: 10.1016/j.gie.2017.04.037]
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