Laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer: Results of postoperative morbidity and mortality from a multicenter randomized controlled trial (SENORITA trial).

초록

Background: The benefits and hazards of laparoscopic sentinel node navigation surgery (LSNNS), compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection (LND) in early gastric cancer (EGC), are unknown. The SENORITA trial investigated the clinical impact of LSNNS in EGC in terms of short-term surgical outcomes, long-term survival and quality of life (QOL). Methods: Patients with preoperatively diagnosed gastric adenocarcinoma with T1N0 of 3 cm or less in diameter, regardless of histology, except absolute indication for endoscopic resection were eligible. Patients were randomized for LSG with LND or LSNNS using dual tracers. The primary endpoint was 3-year disease-free survival. Morbidity and mortality within 30 postoperative days were evaluated as secondary endpoints and graded by Clavien-Dindo (C-D) classification. Results: From March 2013 to December 2016, 580 patients were randomized (LSG arm 292 vs. LSNNS arm 288). After 49 patients dropped out before surgery, operation was performed in 531 patients (272 vs. 259), representing the full analysis set. Excluding 14 without LSNNS due to various reasons, LSNNS by protocol was performed in 245 patients, and detection of the sentinel basin was possible in 237 patients (96.7%). Stomach-preserving surgery was achieved in 210 (81.1%) patients. Postoperative complications occurred in 47 (17.28%) of LSG and 40 (15.44%) of LSNNS patients (p = 0.568). Severe C-D grade 3 and greater complications were noted in 16 (5.88%) and 13 (5.02%) patients, respectively (p = 0.662). Postoperative mortality occurred in one patient in the LSG arm. Postoperative conversion of LSNNS to LSG was performed in 2 patients due to complications of suture line stenosis and 10 patients according to the study protocol (the involved margin of the resected primary tumor, pT2 or greater, and macrometastasis in the sentinel nodes). Conclusions: LSNNS in EGC is a safe procedure compared with LSG with LND in terms of postoperative morbidity and mortality. Long-term survival and QOL of LSNNS will be determined in the future.