Laparoscopic sentinel node navigation surgery versus laparoscopic gastrectomy with lymph node dissection for early gastric cancer: short-term outcomes of a multicentre randomized controlled trial (SENORITA)

Abstract

Background Sentinel node navigation surgery reduces the extent of gastric and lymph node dissection, and may improve quality of life. The benefit and harm of laparoscopic sentinel node navigation surgery (LSNNS) for early gastric cancer is unknown. The SENORITA (SEntinel Node ORIented Tailored Approach) trial investigated the pathological and surgical outcomes of LSNNS compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection. Methods The SENORITA trial was an investigator‐initiated, open‐label, parallel‐assigned, non‐inferiority, multicentre RCT conducted in Korea. The primary endpoint was 3‐year disease‐free survival. The secondary endpoints, morbidity and mortality within 30 days of surgery, are reported in the present study. Results A total of 580 patients were randomized to LSG (292) or LSNNS (288). Surgery was undertaken in 527 patients (LSG 269, LSNNS 258). LSNNS could be performed according to the protocol in 245 of 258 patients, and a sentinel node basin was detected in 237 (96·7 per cent) Stomach‐preserving surgery was carried out in 210 of 258 patients (81·4 per cent). Postoperative complications occurred in 51 patients in the LSG group (19·0 per cent) and 40 (15·5 per cent) in the LSNNS group (P = 0·294). Complications with a Clavien–Dindo grade of III or higher occurred in 16 (5·9 per cent) and 13 (5·0 per cent) patients in the LSG and LSNNS groups respectively (P = 0·647). Conclusion The rate and severity of complications following LSNNS for early gastric cancer are comparable to those after LSG with lymph node dissection. Registration number: NCT01804998 ( http://www.clinicaltrials.gov).

Current status and challenges in sentinel node navigation surgery for early gastric cancer

“…In terms of the type of gastrectomy, stomach-preserving surgery that comprised endoscopic submucosal dissection (ESD), endoscopic full-thickness resection, laparoscopic wedge resection, or laparoscopic segmental resection was carried out in 81% of patients in the SN navigation surgery group. There was no significant difference in the rate of postoperative complications between the groups ( 39 ). A primary survival analysis was reported in 2020, showing that 3-year DFS was 95.5% in the standard gastrectomy group and 91.8% in the SN navigation surgery group [hazard ratio (HR)=1.901, 95% confidence interval (95% CI), 0.911−3.967].…”

Indocyanine green imaging to guide lymphadenectomy in laparoscopic distal gastrectomy - With vídeo

“…The dual-tracer method (ICG and radiolabeled human serum albumin) is been used for LSNNS. Short-term surgical outcomes revealed a comparable rate and severity of postoperative complications between the groups, indicating that LSNNS is feasible and safe [ 34 ].…”

Essential updates 2019/2020: Perioperative and surgical management of gastric cancer

“…In Korea, a phase III RCT, the SENORITA trial, which compared laparoscopic SNNS to conventional gastrectomy with the primary endpoint of 3‐year disease‐free survival (DFS), showed comparable morbidity and mortality rates between the two groups. However, SNNS failed to show non‐inferiority because more recurrence (mainly metachronous gastric cancer) was seen in SNNS (SNNS vs conventional: 91.8% vs 95.5%; HR, 1.901; 95% CI, 0.911‐3.967 [non‐inferiority margin: 2.737]) 15,16 . However, they concluded that SNNS could be an alternative if rescue surgery is appropriately performed; this was supported by 3‐year overall survival (OS) and disease‐specific survival that were equivalent to those of conventional surgery.…”