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)

2019 ◽  
Author(s):  
Ji Yeong An ◽  
Jae Seok Min ◽  
Hoon Hur ◽  
Young Joon Lee ◽  
Gyu Seok Cho ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Postoperative Morbidity ◽  
Phase Iii ◽  
Node Dissection ◽  
Navigation Surgery ◽  
Sentinel Node Navigation Surgery ◽  
Phase Iii Trial ◽  
Multicenter Phase

Laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer: Final three-year survival results of multicenter randomized controlled phase III trial (SENORITA trial).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4510-4510
Author(s):  
Keun Won Ryu ◽  
Young Woo Kim ◽  
Jae Seok Min ◽  
Ji Yeong An ◽  
Hong Man Yoon ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Sentinel Node ◽  
Lymph Node Dissection ◽  
Node Dissection ◽  
Navigation Surgery ◽  
Sentinel Node Navigation Surgery ◽  
Free Survival ◽  
Randomized Controlled

4510 Background: The benefits and hazards of laparoscopic sentinel node navigation surgery (LSNNS), compared with laparoscopic standard gastrectomy (LSG) with lymph node dissection 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. Methods: This study is a prospective, multicenter, randomized controlled, non-inferiority trial. 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 to LSG or LSNNS using dual tracers. The primary endpoint is 3-year disease-free survival (3yDFS). Planned sample size per arm is 290 patients with the non-inferiority margin of 2.737 in hazard ratio (HR) assuming that LSG achieve 97% 3yDFS, 5% of type 1 error and 80% of power. Three-year recurrence-free survival (3yRFS), overall survival (3yOS) and disease specific death rate (3yDSDR) were evaluated as secondary endpoints. Results: From March 2013 to December 2016, 580 patients were randomized (LSG arm 292 vs. LSNNS arm 288). After 53 patients dropped out before surgery, operation was performed in 527 patients (269 vs. 258), representing the full analysis set. LSG was performed in 266 according to the protocol excluding 3 open conversion. After exclusion of 13 without LSNNS due to various reasons, LSNNS was performed in 245 patients according to the protocol. After median follow up of 47.5 months, 3yDFS were 95.5% and 91.8% (HR 1.901, CI 0.911 – 3.967), respectively. The 3yRFS was 98.9% and 95.2% (p=0.019), and 3yOS was 99.2% and 97.6% (p=0.166), and 3yDSDR was 99.5% and 99.1% (p=0.591), respectively. Conclusion: LSNNS in EGC did not show non-inferiority compared with LSG in terms of 3yDFS. However, 3yOS and 3yDSDR of LSNNS were comparable to LSG by the rescue surgery of recurrence. LSNNS might be an alternative surgical option instead of LSG in selected EGC patients. Clinical trial information: NCT01804998 .

scholarly journals A multicenter non-randomized phase III study of sentinel node navigation surgery for early gastric cancer

2020 ◽  
Author(s):  
Satoshi Kamiya ◽  
Hiroya Takeuchi ◽  
Kazumasa Fukuda ◽  
Hirofumi Kawakubo ◽  
Naoto Takahashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Early Gastric Cancer ◽  
Sentinel Node ◽  
Phase Iii ◽  
Sentinel Node Detection ◽  
Navigation Surgery ◽  
Sentinel Node Navigation Surgery ◽  
Long Term Outcome ◽  
Sentinel Nodes ◽  
Phase Iii Study

Abstract This prospective multicenter non-randomized phase III study aims to evaluate the long-term outcome of sentinel node navigation surgery for early gastric cancer compared with conventional distal or total gastrectomy. Clinically diagnosed primary T1N0M0 gastric cancer patients with a single lesion (≤40 mm) and without previous endoscopic treatment will be enrolled in this study. Sentinel nodes are identified by dye and radioisotope tracers and are subjected to intraoperative rapid pathology. For patients with negative sentinel node metastasis, individualized surgery consisting of limited stomach resection and sentinel node basin dissection is performed, while standard gastrectomy with D2 lymph node dissection is employed for the positive sentinel node patients. A total of 225 patients will be accrued from 13 hospitals that have experience in sentinel node mapping. The primary endpoint is 5-year relapse-free survival. The secondary endpoints are overall survival, sentinel node detection rate, diagnostic accuracy for sentinel node, distribution of sentinel nodes and metastatic sentinel node/non-sentinel node, and postoperative quality of life.

Results of interim analysis of the multicenter randomized phase III SENORITA trial of laparoscopic sentinel node oriented, stomach-preserving surgery versus laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4028-4028 ◽  
Author(s):  
Keun Won Ryu ◽  
Young Woo Kim ◽  
Jae Seok Min ◽  
Hong Man Yoon ◽  
Ji Yeong An ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Early Gastric Cancer ◽  
Sentinel Node ◽  
Lymph Node Dissection ◽  
Interim Analysis ◽  
Phase Iii ◽  
Complication Rates ◽  
Node Dissection

4028 Background: The benefits and hazards of laparoscopic sentinel node oriented stomach-preserving surgery, compared to those of laparoscopic standard gastrectomy with lymph node dissection in early gastric cancer (EGC), are unknown. The SENORITA trial investigated the clinical impact of laparoscopic sentinel node oriented stomach-preserving surgery in EGC. Methods: Other than those with absolute indication for endoscopic resection, eligible patients had EGC confined to the mucosa and submucosa, with diameter ≤ 3cm, regardless of histology on preoperative evaluation. Patients were randomized for laparoscopic standard gastrectomy or laparoscopic stomach-preserving surgery. Patients were stratified based on depth (mucosa vs. submucosa) and size (≤ 2cm vs. 2 < ≤ 3cm) of the EGC and by participating institution. The primary endpoint was 3-year disease-free survival (3yDFS). The expected 3yDFS was 97% and non-inferior margin was 5%. 580 patients and 24 events were needed to show non-inferiority with 80% power. One interim analysis was planned after 12 events (50%) occurred. Using the O’Brien-Fleming error spending function, the two-sided nominal significance level for the interim analysis would be 0.0054. Results: From March 2013 to May 2016 462 patients were randomized; analysis was performed in 421 after a dropout of 41 patients. Laparoscopic stomach-preserving surgery was possible in 75.6% by study protocol. Interim analysis was conducted based on 12 events (median follow-up: 15.89 months). The 3yDFS in the laparoscopic standard gastrectomy arm was 96%; the 3yDFS in the laparoscopic stomach-preserving surgery arm was 93%, (99.46% CI: -3.18%, 9.18%). The postoperative complication rates were 15.0% and 12.9%, respectively (p = 0.542). Conclusions: In this interim analysis, laparoscopic sentinel node oriented stomach-preserving surgery did not show non-inferiority for 3yDFS. The follow-up time was not mature enough to evaluate non-inferiority. Further follow-up will elucidate the role of laparoscopic sentinel node oriented stomach-preserving surgery. Clinical trial information: NCT01804998.

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