J Y An1,2, J-S Min3, H Hur4, Y J Lee5, G S Cho6, Y-K Park7, M R Jung7, J-H Park5, W J Hyung1, S-H Jeong5, Y-W Kim8,9, H M Yoon8, B W Eom8, M-C Kook8, M R Han10, B-H Nam11, K W Ryu8. 1. Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea. 2. Department of Surgery, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea. 3. Departments of Surgery, Dongnam Institute of Radiological and Medical Sciences, Cancer Centre, Busan, South Korea. 4. Ajou University School of Medicine, Suwon, South Korea. 5. Gyeongsang National University, Jinju, South Korea. 6. Soonchunhyang University College of Medicine, Bucheon, South Korea. 7. Chonnam National University Medical School, Gwangju, South Korea. 8. Centre for Gastric Cancer. 9. Department of Cancer Control and Population Health, National Cancer Centre Graduate School of Cancer Science and Policy, Goyang, South Korea. 10. Biostatistics Collaboration Team, National Cancer Centre, Goyang, South Korea. 11. Clinical Design Research Centre, HERINGS Institute of Advanced Clinical and Biomedical Research, Seoul, South Korea.
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).
RCT Entities:
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).
Authors: Francesco Belia; Alberto Biondi; Annamaria Agnes; Pietro Santocchi; Antonio Laurino; Laura Lorenzon; Roberto Pezzuto; Flavio Tirelli; Lorenzo Ferri; Domenico D'Ugo; Roberto Persiani Journal: Front Surg Date: 2022-06-28
Authors: Mees Hendrik Siert de Jong; Suzanne Sarah Gisbertz; Mark Ivo van Berge Henegouwen; Werner Adriaan Draaisma Journal: J Gastrointest Oncol Date: 2022-08
Authors: Dong Jin Kim; Woo Jin Hyung; Young-Kyu Park; Hyuk-Joon Lee; Ji Yeong An; Hyoung-Il Kim; Hyung-Ho Kim; Seung Wan Ryu; Hoon Hur; Min-Chan Kim; Seong-Ho Kong; Jin-Jo Kim; Do Joong Park; Keun Won Ryu; Young Woo Kim; Jong Won Kim; Joo-Ho Lee; Han-Kwang Yang; Sang-Uk Han; Wook Kim Journal: Front Surg Date: 2022-09-23