Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection compared with standard gastrectomy with lymphadenectomy in early gastric cancer: A study protocol of a multicenter randomized phase III clinical trial (SENORITA trial).

Abstract

TPS179 Background: Along with marked increase in early gastric cancer (EGC) in Eastern countries, there has been an effort to adopt sentinel node concept in EGC to reduce immediate postoperative complications and preserve gastric function. Based on the promising results from the previous quality control study prior to phase III trial, this prospective multicenter randomized controlled trial aimed to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to standard laparoscopic gastrectomy. Methods: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma with a diameter of 3cm or less are eligible for the present study. A total of 580 patients (290 per each group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, and 5-year DFS and overall survival. The qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. Discussion: The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves the similar oncologic outcomes and improved quality of life compared to the standard gastrectomy in EGC patients. Clinical trial information: NCT01804998.