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).

Authors

null

Keun Won Ryu

National Cancer Center, Goyang, Korea, Republic of (South)

Keun Won Ryu , Young Woo Kim , Jae Seok Min , Ji Yeong An , Hong Man Yoon , Bang Wool Eom , Hoon Hur , Young Joon Lee , Gyu Seok Cho , Young-Kyu Park , Mi Ran Jung , Ji-Ho Park , Woo Jin Hyung , Sang-Ho Jeong , Byung-Ho Nam , Mira Han , Nam Hee Kim

Organizations

National Cancer Center, Goyang, Korea, Republic of (South), Dongnam Institute of Radiological and Medical Sciences, Cancer Center, Busan, Republic of Korea, Yonsei University Severance Hospital, Seoul, Korea, Republic of (South), National Cancer Center, Goyang-Si, Korea, Republic of (South), Ajou University School of Medicine, Suwon, Korea, Republic of (South), Gyeongsang National University College of Medicine, Jinju, Korea, Republic of (South), Soonchunhyang University College of Medicine, Bucheon, Korea, Republic of (South), Chonnam National University Hwasun Hospital, Hwasun, Korea, Republic of (South), Chonnam National University Medical School, Hwasun, Korea, Republic of (South), Gyengsang National University College of Medicine, Jinju, Korea, Republic of (South), Yonsei University College of Medicine, Seoul, Korea, Republic of (South), Biometric Research Branch, Division of Cancer Epidemiology and Prevention, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea, National Cancer Center, Korea, Goyangsi, Korea, Republic of (South)

Research Funding

Other

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. Clinical trial information: NCT01804998

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT01804998

Citation

J Clin Oncol 36, 2018 (suppl; abstr e16043)

DOI

10.1200/JCO.2018.36.15_suppl.e16043

Abstract #

e16043

Abstract Disclosures