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

Abstract

Background: Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy.

Methods/design: This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per 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, 5-year DFS, and overall survival. 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 similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients.

Trial registration: This study was registered at the NIH ClinicalTrial.gov database ( NCT01804998 ) on March 4th, 2013.

Keywords: Gastric cancer; Laparoscopic surgery; Phase III clinical trial; Sentinel lymph node.

Fig. 1

Study scheme of SENORITA trial, inclusion and exclusion criteria, intervention, and end points (EGJ, esophagogastric junction; EGD, esophagogastroduodenoscopy; CT, computed tomography; EUS, endoscopic ultrasonography; LND, lymph node dissection; SBD, sentinel basin dissection; SBN, sentinel basin node; ESD, endoscopic submucosal dissection; EFTR, endoscopic full-thickness resection; LWR, laparoscopic wedge resection; LSR, laparoscopic segmental resection; DFS, disease-free survival; OS, overall survival)