Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Second Department of Surgery, Hamamatsu Medical University School of Medicine, Shizuoka, Japan.
Jpn J Clin Oncol. 2021 Feb 8;51(2):305-309. doi: 10.1093/jjco/hyaa179.
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.
这项前瞻性、多中心、非随机的 III 期研究旨在评估前哨淋巴结导航手术治疗早期胃癌的长期疗效，与传统的远端或全胃切除术进行比较。本研究纳入了经临床诊断的、单发（≤40mm）且未经内镜治疗的 T1N0M0 期原发性胃癌患者。通过染料和放射性同位素示踪剂来识别前哨淋巴结，并进行术中快速病理检查。对于前哨淋巴结无转移的患者，行个体化手术，包括局限性胃切除术和前哨淋巴结区域清扫术，而对于前哨淋巴结阳性的患者，则行标准的 D2 淋巴结清扫术。共有 13 家具有前哨淋巴结示踪经验的医院参与了这项研究，预计将纳入 225 例患者。主要终点是 5 年无复发生存率。次要终点包括总生存率、前哨淋巴结检出率、前哨淋巴结诊断准确性、前哨淋巴结分布及转移前哨淋巴结/非前哨淋巴结、以及术后生活质量。
