Laparoscopic Sentinel Node Navigation Surgery Versus Laparoscopic Standard Gastrectomy with Lymph Node Dissection for Early Gastric Cancer: Postoperative Morbidity and Mortality Results of Prospective Multicenter Phase III Trial (SENORITA)

Abstract

Background: Risks and benefits of laparoscopic sentinel node navigation surgery (LSNNS) compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection (LND) for early gastric cancer (EGC) are unknown. The SENORITA trial investigated the clinical impact of LSNNS for EGC regarding short-term surgical outcomes, long-term survival, and quality of life (QOL). Methods: Patients with preoperatively diagnosed T1N0 gastric adenocarcinoma with a diameter of 3 cm or smaller regardless of histology (except absolute indication for endoscopic resection) were eligible. Patients were randomized to LSG with LND or LSNNS. The primary endpoint was 3-year disease-free survival. Morbidity and mortality within 30 postoperative days were evaluated as secondary endpoints and graded by the Clavien-Dindo classification. Findings: From March 2013 to December 2016, 580 patients were randomized (LSG, 292; LSNNS, 288). Fifty-three patients dropped out before surgery due to various reasons. Surgery was performed for 527 patients (LSG, 269; LSNNS, 258) representing the full analysis set. LSNNS was not performed in 13 patients due to intraoperative findings. LSNNS was performed according to protocol for 245 patients, and detection of sentinel basin was possible for 237 patients (96.7%, 237/245). Stomach-preserving surgery was performed in 210 patients (81.4%. 210/258). Postoperative complications occurred in 51 LSG patients (19.0%) and 40 LSNNS patients (15.5%) (P=0.294). Clavien-Dindo grade III or higher complications occurred in 16 LSG patients (5.9%) and 13 LSNNS patients (5.0%) (P=0.647). Postoperative mortality occurred in one LSG patient. LSNNS was not a risk factor for postoperative morbidity in multivariate analysis except sex. Interpretation: LSNNS for EGC is a safe procedure in terms of postoperative morbidity and mortality when compared with LSG with LND. Results: From March 2013 to December 2016, 580 patients were randomized (LSG, 292; LSNNS, 288). Surgery was performed for 527 patients (LSG, 269; LSNNS, 258) representing the full analysis set. LSNNS was not performed in 13 patients due to intraoperative findings. LSNNS was performed according to protocol for 245 patients, and detection of sentinel basin was possible for 237 patients (96.7%, 237/245). Stomach-preserving surgery was performed in 210 patients (81.4%. 210/258). Postoperative complications occurred in 51 LSG patients (19.0%) and 40 LSNNS patients (15.5%) (P=0.294). Clavien-Dindo grade III or higher complications occurred in 16 LSG patients (5.9%) and 13 LSNNS patients (5.0%) (P=0.647). Postoperative mortality occurred in one LSG patient. LSNNS was not a risk factor for postoperative morbidity in multivariate analysis except sex. Conclusions: LSNNS for EGC is a safe procedure in terms of postoperative morbidity and mortality when compared with LSG with LND. Trial Registration Number: NCT01804998. Funding: National Cancer Center, Republic of Korea (grant number: 1710160-2). Declaration of Interest: The authors declare that they have no conflicts of interest or financial ties to disclose. Ethical Approval: All patients provided written informed consent before the surgery. This study was reviewed and approved by the local institutional review boards of all participating institutions.