Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

Abstract

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD.

Materials and methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications.

Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Trial registration: ClinicalTrials.gov Identifier: NCT03123042.

Keywords: Endoscopic submucosal dissection; Gastric cancer; Sentinel lymph node.

Conflict of interest statement

Conflict of Interest: The authors declare that they have no competing interests. The funder has had no role in any of the following: the design of the study, data collection, analysis, and interpretation, and was not involved in preparing the manuscript.

Figures

Fig. 1. Study scheme of the SENORITA 2 trial.

SENORITA = Sentinel Node Oriented Tailored Approach.

Fig. 2. First endoscopic injection of dual tracer around the ESD ulcer scar (A). Final endoscopic injection around the ESD ulcer scar. Elevated mucosa around the ESD scar by tracer injection is observed (B).

ESD = endoscopic submucosal dissection.

Fig. 3. Intraoperative identification of sentinel basins. Green-stained basin after injection of dual tracer (A) and indocyanine green fluorescence imaging (B-D). Lymphatic vessels draining the tumor and sentinel node are visualized by green (B), blue (C), and bright fluorescence (D).