Department of Surgery, Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea.
Department of Pathology, Seoul National University Bundang Hospital, Seongnam-si, Korea.
Ann Surg Oncol. 2018 Aug;25(8):2357-2365. doi: 10.1245/s10434-018-6523-5. Epub 2018 May 21.
Sentinel node navigation surgery (SNNS) in early gastric cancer (EGC) is technically feasible according to previous literature, however its long-term oncologic safety has not been reported.
A single-center, single-arm, phase II trial was conducted to determine the oncologic outcomes of laparoscopic sentinel node (SN) biopsy in clinical stage T1N0M0 gastric cancer patients. Cases with positive SNs on intraoperative pathologic examination underwent conventional gastrectomy with radical lymphadenectomy (SN-positive group), whereas those with negative SNs underwent laparoendoscopic-limited gastric resections without further lymph node dissections (SN-negative group). The primary endpoint was 3-year relapse-free survival.
Between July 2010 and April 2013, 113 patients were enrolled, with 100 patients being included in the final analysis. SNs were detected in 99 patients. The mean number of identified SNs was 6.1 ± 3.9. Eleven patients were included in the SN-positive group and 89 in the SN-negative group. After a median follow-up period of 46.4 months, four patients died and three showed cancer recurrence. All recurrences occurred on the remnant stomach after endoscopic submucosal resection or wedge resection in the SN-negative group. The 3-year relapse-free and overall survival rates were 96.0% (95% confidence interval [CI] 92.2-100.0%) and 98.0% (95% CI 95.2-100.0%), respectively.
Our results indicate that laparoscopic SNNS may be oncologically safe in EGC. Limited gastric resections should be carefully performed to prevent local recurrence in SN-negative cases. A randomized controlled trial is needed based on the present study.
根据既往文献，前哨淋巴结导航手术（SNNS）在早期胃癌（EGC）中是可行的，但尚未报道其长期肿瘤学安全性。
进行了一项单中心、单臂、Ⅱ期临床试验，以确定腹腔镜前哨淋巴结（SN）活检在临床 T1N0M0 胃癌患者中的肿瘤学结果。术中病理检查 SN 阳性的病例行常规根治性胃切除术和淋巴结清扫术（SN 阳性组），而 SN 阴性的病例行腹腔镜内镜下有限胃切除术，不进行进一步的淋巴结清扫（SN 阴性组）。主要终点为 3 年无复发生存率。
2010 年 7 月至 2013 年 4 月期间，共纳入 113 例患者，其中 100 例纳入最终分析。99 例患者检测到 SN。平均识别 SN 数量为 6.1±3.9。11 例患者纳入 SN 阳性组，89 例患者纳入 SN 阴性组。中位随访 46.4 个月后，4 例患者死亡，3 例患者出现癌症复发。所有复发均发生在 SN 阴性组内镜黏膜下切除或楔形切除后的残胃中。3 年无复发生存率和总生存率分别为 96.0%（95%置信区间 [CI] 92.2-100.0%）和 98.0%（95% CI 95.2-100.0%）。
我们的结果表明，腹腔镜 SNNS 在 EGC 中可能具有肿瘤学安全性。SN 阴性病例应谨慎行有限胃切除术，以预防局部复发。需要根据本研究进行随机对照试验。
