Impact of endobiliary radiofrequency ablation on biliary drainage in patients with malignant biliary strictures treated with uncovered self-expandable metal stents: a randomized controlled multicenter trial

      Background and Aims

      Endobiliary radiofrequency ablation (RFA), usually combined with endoscopic stent insertion, is a simple procedure with the potential to improve stent patency and patient survival for malignant biliary obstruction. We conducted this randomized multicenter trial to evaluate the impact of RFA on stent patency.

      Methods

      Eighty-six patients with malignant biliary obstruction and nonresectable tumors (pancreatic carcinoma, cholangiocarcinoma, or metastases) were included and randomly assigned to receive a self-expandable metal stent (SEMS) only (n = 44) or RFA followed by SEMS insertion (RFA+SEMS, n = 42). The primary outcome measure was stent patency after 3 and 6 months; secondary outcome measures were patient survival and early adverse events within 30 days.

      Results

      Technical success rates for RFA and stent insertion were 100% and 98.8%, respectively. Stent patency after 3 and 6 months did not differ significantly between groups (RFA+SEMS group, 73.1% and 33.3%, respectively; SEMS-only group, 81.8% and 52.4%, respectively; P = .6). Similarly, the addition of RFA did not impact overall survival (hazard ratio, .72; P = .389 for RFA+SEMS). The adverse event rate in the RFA+SEMS group was 10.5% compared with 2.3% in the SEMS-only group, without a statistically significant difference (P = .18).

      Conclusions

      RFA as an addition to SEMS implantation had no positive impact on patency rate or survival. (Clinical trial registration number: DRKS00018993.)

      Graphical abstract

      Abbreviations:

      RFA (radiofrequency ablation), SEMS (self-expandable metal stent)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Ghaneh P.
        • Costello E.
        • Neoptolemos J.P.
        Biology and management of pancreatic cancer.
        Gut. 2007; 56: 1134-1152
        • Khan S.A.
        • Davidson B.R.
        • Goldin R.D.
        • et al.
        Guidelines for the diagnosis and treatment of cholangiocarcinoma: an update.
        Gut. 2012; 61: 1657-1669
        • Fong Z.V.
        • Brownlee S.A.
        • Qadan M.
        • et al.
        The clinical management of cholangiocarcinoma in the United States and Europe: a comprehensive and evidence-based comparison of guidelines.
        Ann Surg Oncol. 2021; 28: 2660-2674
        • Smith A.C.
        • Dowsett J.F.
        • Russell R.C.
        • et al.
        Randomised trial of endoscopic stenting versus surgical bypass in malignant low bileduct obstruction.
        Lancet. 1994; 344: 1655-1660
        • Sawas T.
        • Al Halabi S.
        • Parsi M.A.
        • et al.
        Self-expandable metal stents versus plastic stents for malignant biliary obstruction: a meta-analysis.
        Gastrointest Endosc. 2015; 82: 256-267
        • Hong W.D.
        • Chen X.W.
        • Wu W.Z.
        • et al.
        Metal versus plastic stents for malignant biliary obstruction: an update meta-analysis.
        Clin Res Hepatol Gastroenterol. 2013; 37: 496-500
        • Almadi M.A.
        • 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
        • O'Brien S.
        • Hatfield A.R.
        • Craig P.I.
        • et al.
        A three year follow up of self expanding metal stents in the endoscopic palliation of longterm survivors with malignant biliary obstruction.
        Gut. 1995; 36: 618-621
        • Inoue T.
        • Naitoh I.
        • Okumura F.
        • et al.
        Reintervention for stent occlusion after bilateral self-expandable metallic stent placement for malignant hilar biliary obstruction.
        Dig Endosc. 2016; 28: 731-737
        • Cho J.H.
        • Jeon T.J.
        • Park J.Y.
        • et al.
        Comparison of outcomes among secondary covered metallic, uncovered metallic, and plastic biliary stents in treating occluded primary metallic stents in malignant distal biliary obstruction.
        Surg Endosc. 2011; 25: 475-482
        • 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
        • 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?.
        Dig Dis Sci. 2014; 59: 3099-3102
        • Sharaiha R.Z.
        • Sethi A.
        • Weaver K.R.
        • et al.
        Impact of radiofrequency ablation on malignant biliary strictures: results of a collaborative registry.
        Dig Dis Sci. 2015; 60: 2164-2169
        • 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
        • Kullman E.
        • Frozanpor F.
        • Söderlund C.
        • et al.
        Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study.
        Gastrointest Endosc. 2010; 72: 915-923
        • R Core Team
        R: a language and environment for statistical computing.
        R Foundation for Statistical Computing, Vienna, Austria2016
        • Wickham H.
        • Averick M.
        • Bryan J.
        • et al.
        Welcome to the Tidyverse.
        J Open Source Softw. 2019; 4: 1686
        • Wilkinson L.
        ggplot2: elegant graphics for data analysis by Wickham, H.
        Biometrics. 2011; 67: 678-679
        • Therneau TM
        A package for survival analysis in S.
        2015 (Available at:)
        https://CRAN.R-project.org/package=survival
        Date accessed: January 20, 2022
        • Kassambara A.
        • Kosinski M.
        • Biecek P.
        Drawing survival curves using “ggplot2” [R package survminer version 0.4.8].
        2020 (Available at: https://CRAN.R-project.org/package=survminer. Accessed January 20, 2022)
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Wu T.T.
        • Li W.M.
        • Li H.C.
        • et al.
        Percutaneous intraductal radiofrequency ablation for extrahepatic distal cholangiocarcinoma: a method for prolonging stent patency and achieving better functional status and quality of life.
        Cardiovasc Intervent Radiol. 2017; 40: 260-269
        • Cui W.
        • Wang Y.
        • Fan W.
        • et al.
        Comparison of intraluminal radiofrequency ablation and stents vs. stents alone in the management of malignant biliary obstruction.
        Int J Hyperthermia. 2017; 33: 853-861
        • Yu T.
        • Zhang W.
        • Li C.
        • et al.
        Percutaneous intraductal radiofrequency ablation combined with biliary stent placement for treatment of malignant biliary obstruction.
        Abdom Radiol. 2020; 45: 3690-3697
        • Kong Y.L.
        • Zhang H.Y.
        • Liu C.L.
        • et al.
        Improving biliary stent patency for malignant obstructive jaundice using endobiliary radiofrequency ablation: experience in 150 patients.
        Surg Endosc. 2022; 36: 1789-1798
        • Dutta A.K.
        • Basavaraju U.
        • Sales L.
        • et al.
        Radiofrequency ablation for management of malignant biliary obstruction: a single-center experience and review of the literature.
        Expert Rev Gastroenterol Hepatol. 2017; 11: 779-784
        • Yang J.
        • Wang J.
        • Zhou H.
        • et al.
        Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial.
        Endoscopy. 2018; 50: 751-760
        • Isayama H.
        • Nakai Y.
        • Kogure H.
        • et al.
        Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered?.
        Dig Endosc. 2013; 25: 71-74
        • Kwon C.I.
        • Lehman G.A.
        Mechanisms of biliary plastic stent occlusion and efforts at prevention.
        Clin Endosc. 2016; 49: 139-146
        • Inoue T.
        • Yoneda M.
        Updated evidence on the clinical impact of endoscopic radiofrequency ablation in the treatment of malignant biliary obstruction.
        Dig Endosc. 2022; 34: 345-358
        • Gao D.J.
        • Yang J.F.
        • Ma S.R.
        • et al.
        Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial.
        Gastrointest Endosc. 2021; 94: 91-100
        • Kang H.
        • Chung M.J.
        • Cho I.R.
        • et al.
        Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL.
        Surg Endosc. 2021; 35: 63-73
        • Bokemeyer A.
        • Matern P.
        • Bettenworth D.
        • et al.
        Endoscopic radiofrequency ablation prolongs survival of patients with unresectable hilar cholangiocellular carcinoma—a case-control study.
        Sci Rep. 2019; 913685
        • Haen S.P.
        • Pereira P.L.
        • Salih H.R.
        • et al.
        More than just tumor destruction: immunomodulation by thermal ablation of cancer.
        Clin Dev Immunol. 2011;
        • Hansler J.
        • Wissniowski T.T.
        • Schuppan D.
        • et al.
        Activation and dramatically increased cytolytic activity of tumor specific T lymphocytes after radio-frequency ablation in patients with hepatocellular carcinoma and colorectal liver metastases.
        World J Gastroenterol. 2006; 12: 3716-3721
        • Llovet J.M.
        • De Baere T.
        • Kulik L.
        • et al.
        Locoregional therapies in the era of molecular and immune treatments for hepatocellular carcinoma.
        Nat Rev Gastroenterol Hepatol. 2021; 18: 293-313
        • Ruzzenente A.
        • Manzoni G.D.
        • Molfetta M.
        • et al.
        Rapid progression of hepatocellular carcinoma after radiofrequency ablation.
        World J Gastroenterol. 2004; 10: 1137-1140
        • Zhang N.
        • Li H.
        • Qin C.
        • et al.
        Insufficient radiofrequency ablation promotes the metastasis of residual hepatocellular carcinoma cells via upregulating flotillin proteins.
        J Cancer Res Clin Oncol. 2019; 145: 895-907
        • Yoshida S.
        • Kornek M.
        • Ikenaga N.
        • et al.
        Sublethal heat treatment promotes epithelial-mesenchymal transition and enhances the malignant potential of hepatocellular carcinoma.
        Hepatology. 2013; 58: 1667-1680
        • Cho J.H.
        • Lee K.H.
        • Kim J.M.
        • et al.
        Safety and effectiveness of endobiliary radiofrequency ablation according to the different power and target temperature in a swine model.
        J Gastroenterol Hepatol. 2017; 32: 521-526

      Linked Article

      • The debate on whether to ablate
        Gastrointestinal EndoscopyVol. 96Issue 6
        • Preview
          You’d think that if you ablate a tumor causing a biliary obstruction before placing a stent, it should be better than just placing a stent, right? In fact, we already have studies to support this.1,2 Well?... An ancient philosopher, Phaedrus, supposedly said, “Things are not always what they seem; the first appearance deceives many; the intelligence of a few perceives what has been carefully hidden.”
        • Full-Text
        • PDF