Prospective multicenter feasibility study of laparoscopic sentinel basin dissection after endoscopic submucosal dissection for early gastric cancer

초록

Background: Although standard radical gastrectomy is recommended after non-curative resection of endoscopic submucosal dissection for early gastric cancer, in most cases, no residual tumor and no lymph node metastasis was revealed after surgery. Lymph node metastasis can be evaluated using sentinel basin dissection, however, there was no evidence that sentinel lymph node concept can be applied after endoscopic resection. Trial design: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent endoscopic submucosal dissection for clinical stage T1N0M0 gastric cancer and the resections were proven as non-curative were eligible. Qualified investigators who completed the prior phase III trial (Senorita I) are exclusively allowed to participate in this study. Intraoperative endoscopic submucosal injection of a standardized dual tracer was administered to normal mucosa nearby the scar, and sentinel basins were detected using gamma-probe and dissected. Then, standard laparoscopic gastrectomy with lymphadenectomy was performed. Sample size was calculated based on inferior confidence interval of detection rate of 95%, and estimated accrual was 237. The primary and secondary end-points were detection rate and sensitivity of sentinel basin, respectively. This study is expected to evaluate the feasibility of laparoscopic sentinel basin dissection after endoscopic submucosal dissection. If the feasibility is identified, multicenter phase III trial will be started comparing laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection. Clinical trial identification: NCT03123042; registered April 21st, 2017. Legal entity responsible for the study: Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.