Endoscopic radiofrequency ablation plus plastic stent placement versus stent placement alone for unresectable extrahepatic biliary cancer: a multicenter randomized controlled trial

  • Author Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Dao-Jian Gao
    Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Affiliations
    Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China
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  • Author Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Jian-Feng Yang
    Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Affiliations
    Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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  • Author Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Shu-Ren Ma
    Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    Affiliations
    Department of Endoscopy, General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China
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  • Jun Wu
    Affiliations
    Department of Gastroenterology, Third Affiliated Hospital, Second Military Medical University, Jiading District, Shanghai, China
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  • Tian-Tian Wang
    Affiliations
    Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China
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  • Hang-Bin Jin
    Affiliations
    Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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  • Ming-Xing Xia
    Affiliations
    Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China
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  • Ying-Chun Zhang
    Affiliations
    Department of Endoscopy, General Hospital of Shenyang Military Region, Shenyang, Liaoning Province, China
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  • Hong-Zhang Shen
    Affiliations
    Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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  • Xin Ye
    Affiliations
    Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China
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  • Author Footnotes
    † Drs Zhang and Hu contributed equally to this article.
    Xiao-Feng Zhang
    Footnotes
    † Drs Zhang and Hu contributed equally to this article.
    Affiliations
    Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China
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  • Author Footnotes
    † Drs Zhang and Hu contributed equally to this article.
    Bing Hu
    Correspondence
    Reprint requests: Bing Hu, MD, PhD, Department of Gastroenterology and Endoscopy, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, 225 Changhai Rd, Shanghai 200438, China.
    Footnotes
    † Drs Zhang and Hu contributed equally to this article.
    Affiliations
    Department of Gastroenterology, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Yangpu District, Shanghai, China

    Department of Gastroenterology, Third Affiliated Hospital, Second Military Medical University, Jiading District, Shanghai, China
    Search for articles by this author
  • Author Footnotes
    ∗ Drs Gao, Yang, and Ma are co–first authors.
    † Drs Zhang and Hu contributed equally to this article.
Published:December 23, 2020DOI:https://doi.org/10.1016/j.gie.2020.12.016

      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

      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)
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      Linked Article

      • Endoscopic radiofrequency ablation to prolong survival for unresectable extrahepatic biliary cancer
        Gastrointestinal EndoscopyVol. 94Issue 1
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          For 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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