A multicenter non-randomized phase III study of sentinel node navigation surgery for early gastric cancer

Satoshi Kamiya, Hiroya Takeuchi, Kazumasa Fukuda, Hirofumi Kawakubo, Naoto Takahashi, Norio Mitsumori, Masanori Terashima, Hironori Tsujimoto, Shinichi Kinami, Shoji Natsugoe, Masaki Ohi, Shinichi Kadoya, Sachio Fushida, Hideki Hayashi, Kazuhito Nabeshima, Junichi Sakamoto, Satoru Matsuda, Shuhei Mayanagi, Tomoyuki Irino, Yasunori SatoYuko Kitagawa

研究成果: Article査読

1 被引用数 (Scopus)

抄録

This prospective multicenter non-randomized phase III study aims to evaluate the long-term outcome of sentinel node navigation surgery for early gastric cancer compared with conventional distal or total gastrectomy. Clinically diagnosed primary T1N0M0 gastric cancer patients with a single lesion (≤40 mm) and without previous endoscopic treatment will be enrolled in this study. Sentinel nodes are identified by dye and radioisotope tracers and are subjected to intraoperative rapid pathology. For patients with negative sentinel node metastasis, individualized surgery consisting of limited stomach resection and sentinel node basin dissection is performed, while standard gastrectomy with D2 lymph node dissection is employed for the positive sentinel node patients. A total of 225 patients will be accrued from 13 hospitals that have experience in sentinel node mapping. The primary endpoint is 5-year relapse-free survival. The secondary endpoints are overall survival, sentinel node detection rate, diagnostic accuracy for sentinel node, distribution of sentinel nodes and metastatic sentinel node/non-sentinel node, and postoperative quality of life.

本文言語English
ページ(範囲)305-309
ページ数5
ジャーナルJapanese journal of clinical oncology
51
2
DOI
出版ステータスPublished - 2021 2 8

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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