RANDOMIZED CONTROLLED TRIAL COMPARING CONVENTIONAL AND TRACTION ENDOSCOPIC SUBMUCOSAL DISSECTION FOR EARLY COLON TUMOR(CONNECT-C TRIAL)

DOI
  • ICHIJIMA Ryoji
    Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine.
  • IKEHARA Hisatomo
    Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine.
  • SUMIDA Yorinobu
    Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center.
  • INADA Taisuke
    Department of Gastroenterology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center.
  • NEMOTO Daiki
    Department of Coloproctology, Fukushima Medical University Aizu Medical Center.
  • NAKAJIMA Yuki
    Department of Coloproctology, Fukushima Medical University Aizu Medical Center.
  • MINAGAWA Takeyoshi
    Department of Gastroenterology, Tonan Hospital.
  • SUMIYOSHI Tetsuya
    Department of Gastroenterology, Tonan Hospital.
  • INOKI Kazuya
    Division of Gastroenterology, Department of Medicine, Showa University School of Medicine.
  • YOSHIDA Naohisa
    Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine.
  • INOUE Ken
    Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine.
  • FUKUZAWA Masakatsu
    Department of Gastroenterology and Hepatology, Tokyo Medical University.
  • MINODA Yosuke
    Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University.
  • TSUTSUMI Koshiro
    Department of Gastroenterology, Faculty of Medicine, Oita University.
  • ESAKI Mitsuru
    Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University. Department of Gastroenterology, Kitakyushu Municipal Medical Center.
  • GOTODA Takuji
    Division of Gastroenterology and Hepatology, Department of Medicine, Nihon University School of Medicine.

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Other Title
  • 大腸腫瘍に対する従来型ESDおよび牽引ESDの無作為化比較試験（CONNECT-C試験）

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Abstract

<p>Objectives: Endoscopic submucosal dissection (ESD) is a widely used treatment for early gastrointestinal cancer. However, colon ESD remains challenging. Previous studies on colon ESD using the traction method used a small sample, single-center design, providing insufficient evidence of this procedureʼs efficacy. We thus aimed to investigate the efficacy and safety of the traction method in colon ESD in this multicenter randomized trial.</p><p>Methods: We conducted a prospective, multicenter, randomized, two-arm controlled trial at 10 facilities in Japan. A 1:1 allocation was conducted for the conventional ESD (C-ESD) and traction ESD (T-ESD) groups. The primary end-point was ESD procedure time.</p><p>Results: We included 128 C-ESD and 123 T-ESD cases from April 2020 to August 2021. The median procedure times for C-ESD and T-ESD were 61 (40-100) and 53 (40-76) min (p = 0.18), respectively, and no significant differences were observed between the groups. Subgroup analysis showed that the median procedure times for patients with a lesion diameter of ≥30 mm in the C-ESD and T-ESD groups were 89 (57-80) and 69 (50-104) min (p = 0.05), respectively, and for nonexpert operators were 81 (62-120) and 64 (52-109) min (p = 0.07), respectively.</p><p>Conclusions: The traction method did not contribute to a significantly shortened ESD procedure time. However, this method may be useful when the tumor diameter is large or if the procedure is conducted by nonexpert endoscopists.</p>

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