Journal of Gastric Cancer

  • 제19권2호
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  • Pages.157-164
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  • 2019
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  • 2093-582X(pISSN)
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  • 2093-5641(eISSN)
대한위암학회 (The Korean Gastric Cancer Association)
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Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool (Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center) ;
  • Yoon, Hong Man (Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center) ;
  • Min, Jae Seok (Department of Surgery, Dongnam Institute of Radiological and Medical Science) ;
  • Cho, In (Department of Surgery, Soonchunhyang University College of Medicine) ;
  • Park, Ji-Ho (Department of Surgery, Gyeongsang National University) ;
  • Jung, Mi Ran (Department of Surgery, Chonnam National University Hwasun Hospital) ;
  • Hur, Hoon (Department of Surgery, Ajou University School of Medicine) ;
  • Kim, Young-Woo (Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center) ;
  • Park, Young Kyu (Department of Surgery, Chonnam National University Hwasun Hospital) ;
  • Nam, Byung-Ho (Biometric Research Branch, Research Institute for National Cancer Control & Evaluation, National Cancer Center) ;
  • Ryu, Keun Won (Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center) ;
  • Sentinel Node Oriented Tailored Approach (SENORITA) Study Group (Sentinel Node Oriented Tailored Approach (SENORITA) Study Group)
  • 투고 : 2018.10.20
  • 심사 : 2019.03.04
  • 발행 : 2019.06.28
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초록

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

키워드

참고문헌

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피인용 문헌

  1. Sentinel-Lymph-Node Multicenter Trials vol.50, pp.1, 2020, https://doi.org/10.1053/j.semnuclmed.2019.10.001
  2. Function-Preserving Gastrectomy for Early Gastric Cancer vol.13, pp.24, 2019, https://doi.org/10.3390/cancers13246223
  3. What’s New with Endoscopic Treatments for Early Gastric Cancer in the “Post-ESD Era”? vol.103, pp.1, 2019, https://doi.org/10.1159/000518892