Background and Aims
We sought to compare the efficacy and safety between endoscopic radiofrequency ablation
(RFA) and stent placement alone in patients with unresectable extrahepatic biliary
cancer (EBC).
Methods
In this randomized controlled trial, patients with locally advanced or metastatic
cholangiocarcinoma (CCA) or ampullary cancer who were unsuitable for surgery were
recruited from 3 tertiary centers. Eligible patients were randomly assigned to RFA
plus plastic stent placement (RFA group) or plastic stent placement alone (stent placement
alone group) in a 1:1 ratio. Both groups underwent 2 scheduled interventions with
an interval of approximately 3 months. The primary outcome was overall survival (OS).
Results
Altogether, 174 participants completed the 2 index endoscopic interventions. No significant
differences in baseline characteristics were noted between the 2 groups. The median
OS was significantly higher in the RFA group (14.3 vs 9.2 months; hazard ratio, .488;
95% confidence interval, .351-.678; P < .001). A survival benefit was also shown in patients with CCA (13.3 vs 9.2 months;
hazard ratio, .546; 95% confidence interval, .386-.771; P < .001). However, no significant between-group differences were found in jaundice
control or stent patency duration. The postprocedural Karnofsky performance scores
were significantly higher in the RFA group until 9 months (all P < .001). Adverse events were comparable between the 2 groups (27.6% vs 19.5%, P = .211), except for acute cholecystitis, which was more frequently observed in the
RFA group (9 vs 0, P = .003).
Conclusions
Compared with stent placement alone, additional RFA may improve OS and quality of
life of patients with inoperable primary EBC who do not undergo systemic treatments.
(Clinical trial registration number: NCT01844245.)
Graphical abstract
Graphical Abstract
Abbreviations:
AC (ampullary cancer), CCA (cholangiocarcinoma), CI (confidence interval), EBC (extrahepatic biliary cancer), HR (hazard ratio), KPS (Karnofsky performance status), OS (overall survival), RCT (randomized controlled trial), RFA (radiofrequency ablation), SEMS (self-expandable metal stent)To read this article in full you will need to make a payment
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References
- Guidelines for the diagnosis and treatment of cholangiocarcinoma: consensus document.Gut. 2002; 51: VI1-VI9
- Cholangiocarcinoma: thirty-one-year experience with 564 patients at a single institution.Ann Surg. 2007; 245: 755-762
- Cholangiocarcinoma: anatomical location-dependent clinical, prognostic, and genetic disparities.Ann Transl Med. 2019; 7: 744
- Racial and ethnic disparities in a national cohort of ampullary cancer patients.J Surg Oncol. 2018; 117: 220-227
- Optimal stent placement strategy for malignant hilar biliary obstruction: a large multicenter parallel study.Gastrointest Endosc. 2020; 91: 1117-1128
- Unilateral versus bilateral hilar stents for the treatment of cholangiocarcinoma: a multicenter international study.Ann Gastroenterol. 2020; 33: 202-209
- Endoscopically applied radiofrequency ablation appears to be safe in the treatment of malignant biliary obstruction.Gastrointest Endosc. 2011; 73: 149-153
- 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
- Impact of radiofrequency ablation on malignant biliary strictures: results of a collaborative registry.Dig Dis Sci. 2015; 60: 2164-2169
- Analysis of endoscopic radiofrequency ablation of biliary malignant strictures in pancreatic cancer suggests potential survival benefit.Dig Dis Sci. 2015; 60: 3449-3455
- Endoscopic radiofrequency ablation for malignant biliary obstruction: a nationwide retrospective study of 84 consecutive applications.Surg Endosc. 2014; 28: 854-860
- Third metal stent for revision of malignant hilar biliary strictures.Endoscopy. 2016; 48: 1129-1133
- Unilateral versus bilateral endoscopic metal stenting for malignant hilar biliary obstruction.J Gastroenterol Hepatol. 2009; 24: 552-557
- A lexicon for endoscopic adverse events: report of an ASGE workshop.Gastrointest Endosc. 2010; 71: 446-454
- Amin M.B. Edge S. Greene F. AJCC cancer staging manual. 8th ed. Springer, New York, NY2016
- Endobiliary radiofrequency ablation improve overall survival of cholangiocarcinoma: a multi-center randomized control study [abstract].Gastrointest Endosc. 2016; 83: AB126
- Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study.PLoS One. 2018; 13e0206694
- In situ tumor ablation creates an antigen source for the generation of antitumor immunity.Cancer Res. 2004; 64: 4024-4029
- 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
- Immunomodulation after radiofrequency ablation of locally advanced pancreatic cancer by monitoring the immune response in 10 patients.Pancreatology. 2017; 17: 962-966
- Percutaneous intraductal radiofrequency ablation combined with biliary stent placement for nonresectable malignant biliary obstruction improves stent patency but not survival.Medicine (Baltimore). 2016; 95: e3329
- 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
- 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
- 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
- Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial.Endoscopy. 2018; 50: 751-760
- Palliation of malignant biliary obstruction: a prospective trial examining impact on quality of life.Gastrointest Endosc. 2002; 56: 835-841
- Percutaneous intraluminal radiofrequency ablation for malignant extrahepatic biliary obstruction: a safe and feasible method.Dig Dis Sci. 2015; 60: 2158-2163
- Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer.N Engl J Med. 2010; 362: 1273-1281
- Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan.Br J Cancer. 2010; 103: 469-474
Article info
Publication history
Published online: December 23, 2020
Accepted:
December 9,
2020
Received:
September 10,
2020
Footnotes
DISCLOSURE: All authors disclosed no financial relationships. Research support for this study was provided in part by grants from the State Key Project on Infectious Diseases of China (2012zx10002016003004), Hangzhou Medical and Health Science and Technology Plan (2016ZD01), Hangzhou Major Science and Technology Projects (20162013A01), and Natural Science Foundation of Zhejiang Province (LY17H030003). The funders had no role in the study design, data collection, and analysis, decision to publish, or preparation of the manuscript.
See CME section, p. 178.
If you would like to chat with an author of this article, you may contact Dr Hu at [email protected]
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- Endoscopic radiofrequency ablation to prolong survival for unresectable extrahepatic biliary cancerGastrointestinal EndoscopyVol. 94Issue 1
- PreviewFor patients with unresectable extrahepatic biliary cancer, the best supportive care to relieve biliary obstruction consists of plastic or metal stent placement. As such, endoscopic drainage is associated with a lower complication rate than is surgical decompression.1 In this issue of Gastrointestinal Endoscopy, Gao et al2 report a randomized controlled trial on the added value of endoscopic radiofrequency ablation (RFA) in combination with stent placement for malignant extrahepatic obstruction.
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