Phase II, prospective, single-arm, single-institutional, open-label clinical trial on laparoscopic sentinel node navigation surgery in early gastric cancer.

Abstract

90 Background: The aim of this study was to evaluate the feasibility and safety of laparoscopic limited gastrectomy with sentinel basin (SB) dissection for gastric cancer using simultaneous indocyanine green and 99mTc-antimony sulfur colloid injections. Methods: The primary end point was the 3-year relapse-free survival rate of the patients who underwent laparoscopic sentinel node navigation surgery (SNNS). Secondary end points included sentinel node (SN) detection rate, false negative rate of intraoperative pathologic examinations for metastatic SN detection, postoperative morbidity and mortality, quality of life (QOL), and overall survival. Results: From July 2010 to April 2013, 100 patients were enrolled to this study. The SBs were identified in all patients (100%) by dual method. The mean number of SN and non-SN was 6.07 ± 3.84 [range 0-17] and 4.60 ± 4.76 [range 0-25]. Eleven patients had SN metastasis and they were converted to conventional laparoscopic gastrectomy with radical lymphadenectomy. Among 89 patients with negative SNs, 3 patients were considered as false negative of intraoperative pathological examination (3.37%). There was no significant difference between SN negative (n = 89) and positive (n = 11) groups in estimated blood loss, postoperative hospital stays and complication rate. Overall, QOL scores are more likely to be better in SNNS group than in conventional laparoscopic distal gastrectomy group. After median follow-up periods of 47.5 months in all patients, 4 patients who underwent SNNS died, and 2 patients who underwent SNNS had recurrences of cancer. The 3-year relapse-free survival rate for all patients (n = 100) was 97.0 %. In the subgroup analysis, the 3-year relapse-free for the SN negative group was 96.6%, and 100% for the SN positive group (P = 0.374). The 3-year overall survival rate was 98.0% for all patients; 97.7% for the SN negative group and 100% for the SN positive group (P = 0.418). Conclusions: Laparoscopic SNNS was feasible and safe in early gastric cancer. Phase III randomized controlled trial on comparing laparoscopic SNNS and conventional laparoscopic gastrectomy will be needed based on the present study. Clinical trial information: NCT01441310.