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Prospective study of endoscopic focal cryoballoon ablation for esophageal squamous cell neoplasia in China

  • Author Footnotes
    ∗ Drs Ke and van Munster contributed equally to this article.
    Yan Ke
    Correspondence
    Reprint requests: Yan Ke, National Cancer Center, National Clinical Research Center for Cancer, 17# Pan Jiayuan Nanli, Chaoyang District, Beijing 100021, China.
    Footnotes
    ∗ Drs Ke and van Munster contributed equally to this article.
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Author Footnotes
    ∗ Drs Ke and van Munster contributed equally to this article.
    Sanne N. van Munster
    Footnotes
    ∗ Drs Ke and van Munster contributed equally to this article.
    Affiliations
    Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands

    Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands
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  • Liyan Xue
    Affiliations
    Department of Pathology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China
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  • Shun He
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Yueming Zhang
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Lizhou Dou
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Yong Liu
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Xudong Liu
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Yumeng Liu
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Wei Li
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Ning Lv
    Affiliations
    Department of Pathology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China
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  • Sanford M. Dawsey
    Affiliations
    Department of Cancer Epidemiology & Genetics, National Cancer Institute, Bethesda, Maryland, USA
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  • Bas L.A.M. Weusten
    Affiliations
    Department of Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands

    Department of Gastroenterology & Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands
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  • Jacques J.G.H.M. Bergman
    Affiliations
    Department of Gastroenterology & Hepatology, Amsterdam University Medical Center, Amsterdam, the Netherlands
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  • Guiqi Wang
    Affiliations
    Department of Endoscopy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
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  • Author Footnotes
    ∗ Drs Ke and van Munster contributed equally to this article.
Published:March 25, 2019DOI:https://doi.org/10.1016/j.gie.2019.03.017

      Background and Aims

      Esophageal squamous cell neoplasia (ESCN) has a significant risk for progression to cancer. Current treatment options, endoscopic mucosal resection (EMR) or submucosal dissection (ESD), have their limitations. The cryoballoon focal ablation system (CbFAS) is a novel endoscopic ablation therapy device. We aimed to assess the safety, tolerability, and efficacy of CbFAS for eradication of ESCN.

      Methods

      In this single-center prospective trial in China, patients with 1 flat unstained lesion (USL) on Lugol chromoendoscopy that contained moderate- or high-grade intraepithelial neoplasia (MGIN or HGIN, respectively) were enrolled. CbFAS was performed using side-by-side applications of 10 seconds, treatment was repeated at 3-month intervals until a complete response (CR) was established. The response at 12 months was the primary trial endpoint. Safety phone calls were performed at 2, 7, and 30 days after the initial CbFAS.

      Results

      We enrolled 80 patients (59 MGIN, 21 HGIN) with a median USL length of 3 cm (interquartile range [IQR], 3-4). Seventy-nine received treatment, with a median of 5 side-by-side applications (IQR, 4-7) per patient over a median of 8 minutes (IQR, 5-10). After a single treatment, 70 of 78 patients (90%) exhibited CR, and 1 was lost to follow-up. The other 8 with persisting USLs were retreated, and all achieved CR after this second treatment. At 12 months after the initial CbFAS, 76 of 78 patients (97%) exhibited CR and 2 (3%) had recurrent MGIN. No strictures or serious adverse events occurred. Four patients developed self-limiting mucosal lacerations on balloon inflation. The postprocedure median pain score was 1 of 10 (IQR, 0-2) at day 2 and 0 (0-0) at days 7 and 30.

      Conclusions

      The results suggest that the CbFAS is safe, well tolerated, and effective in inducing endoscopic and histologic remission in patients with ESCN of limited size. (Clinical trial registration number: NCT02605759.)

      Abbreviations:

      CbFAS (cryoballoon focal ablation system), CR (complete response), ESCC (esophageal squamous cell carcinoma), ESCN (esophageal squamous cell neoplasia), ESD (endoscopic submucosal dissection), HGIN (high-grade intraepithelial neoplasia), IQR (interquartile range), LGIN (low-grade intraepithelial neoplasia), MGIN (moderate-grade intraepithelial neoplasia), RFA (radiofrequency ablation), TA (treatment area), USL (unstained lesion)
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      Linked Article

      • The Ice Age reborn?
        Gastrointestinal EndoscopyVol. 90Issue 2
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          Esophageal cancer is the sixth most common cause of cancer-related death worldwide, with esophageal squamous cell cancer (ESCC) being the dominant variety, particularly in developing countries.1 In China, where up to half of all cases occur, ESCC is the fourth leading cause of cancer death.2 Given the high prevalence of this disease in North Central China, an endoscopic screening program has been initiated in this high-risk region, with resultant decreases in cumulative incidence and ESCC-related death.
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