Results of the interim analysis of a prospective, multicenter, observational study of small subepithelial lesions in the stomach

  • Masaya Iwamuro
    Department of Gastroenterology and Hepatology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama Japan
  • Toshiharu Mitsuhashi
    Center for Innovative Clinical Medicine Okayama University Hospital Okayama Japan
  • Tomoki Inaba
    Department of Gastroenterology Kagawa Prefectural Central Hospital Kagawa Japan
  • Kazuhiro Matsueda
    Department of Gastroenterology and Hepatology Kurashiki Central Hospital Okayama Japan
  • Teruya Nagahara
    Department of Gastroenterology Mitoyo General Hospital Kagawa Japan
  • Yoji Takeuchi
    Department of Gastrointestinal Oncology Osaka International Cancer Institute Osaka Japan
  • Hisashi Doyama
    Department of Gastroenterology Ishikawa Prefectural Central Hospital Ishikawa Japan
  • Masakatsu Mizuno
    Department of Internal Medicine Japanese Red Cross Mihara Hospital Hiroshima Japan
  • Tomoyuki Yada
    Department of Gastroenterology and Hepatology Kohnodai Hospital, National Center for Global Health and Medicine Chiba Japan
  • Yoshinari Kawai
    Department of Gastroenterology Onomichi Municipal Hospital Hiroshima Japan
  • Jun Nakamura
    Department of Endoscopy Fukushima Medical University Hospital Fukushima Japan
  • Minoru Matsubara
    Department of Internal Medicine Sumitomo Besshi Hospital Ehime Japan
  • Hiroko Nebiki
    Department of Gastroenterology Osaka City General Hospital Osaka Japan
  • Keiko Niimi
    Department of Gastroenterology The University of Tokyo Hospital Tokyo Japan
  • Tatsuya Toyokawa
    Department of Gastroenterology National Hospital Organization Fukuyama Medical Center Hiroshima Japan
  • Ryuta Takenaka
    Department of Internal Medicine Tsuyama Chuo Hospital Okayama Japan
  • Sho Takeda
    Department of Internal Medicine Teraoka Memorial Hospital Hiroshima Japan
  • Shouichi Tanaka
    Department of Gastroenterology National Hospital Organization Iwakuni Clinical Center Yamaguchi Japan
  • Mamoru Nishimura
    Department of Internal Medicine Okayama City Hospital Okayama Japan
  • Takao Tsuzuki
    Department of Internal Medicine Japanese Red Cross Society Himeji Hospital Hyogo Japan
  • Kazuya Akahoshi
    Department of Gastroenterology Iizuka Hospital Fukuoka Japan
  • Takahisa Furuta
    Center for Clinical Research Hamamatsu University School of Medicine Shizuoka Japan
  • Ken Haruma
    Department of General Internal Medicine 2 Kawasaki Medical School General Medical Center Okayama Japan
  • Hiroyuki Okada
    Department of Internal Medicine Japanese Red Cross Society Himeji Hospital Hyogo Japan

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<jats:sec><jats:title>Objectives</jats:title><jats:p>Long‐term outcomes of gastric subepithelial lesions have not been elucidated. To reveal the natural history, we initiated a prospective, 10‐year follow‐up of patients with small (≤20 mm) gastric subepithelial lesions in September 2014. Here, we report the results of an interim analysis of a prospective observational study.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In total, 567 patients with 610 lesions were prospectively registered between September 2014 and August 2016. The location, size, morphology, and number of subepithelial lesions were recorded on a web‐based case report form. This study has been conducted as an Academic Committee Working Group of the Japan Gastroenterological Endoscopy Society.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>The endoscopic follow‐up period was 4.60 ± 1.73 years (mean ± standard deviation), and survival data were investigated for 5.28 ± 1.68 years. This interim analysis revealed that the estimated cumulative incidence of a size increase ≥5 mm, after accounting for patients' death and resection of the tumor as competing risk events, was 4.5% at 5 years. In addition, the estimated cumulative incidence of lesion size increase ≥5 mm or resection of lesions was 7.9% at 5 years, and that of size increase ≥10 mm or resection of lesions was 4.5% at 5 years.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>These results indicate that approximately one in 13 patients with small (≤20 mm) gastric subepithelial lesions may require resection or further investigation for increased tumor size (≥5 mm) within 5 years.</jats:p></jats:sec>

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