Long-Term Oncologic Outcomes of Laparoscopic Sentinel Node Navigation Surgery in Early Gastric Cancer: A Single-Center, Single-Arm, Phase II Trial

Abstract

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.