Spots Global Cancer Trial Database for Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)

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Trial Identification

Brief Title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)

Official Title: Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4 Trial)

Study ID: NCT05978882

Conditions

Early Gastric Cancer

Interventions

Laparoscopic sentinel navigation surgery using fluorescence

Study Description

Brief Summary: SENORITA 1 trial showed laparoscopic sentinel lymph node biopsy and stomach preserving surgery in early gastric cancer can increase the quality of life. (Ryu KW et al. JCO 2022) The radioactive isotope is difficult to use because of the hazard of radiation and shortage of materials. The aim of this study is to investigate whether laparoscopic sentinel lymph node biopsy and stomach-preserving surgery using only fluorescence is feasible.

Detailed Description: 1. Injection of Indocyanine Green (ICG) * Endoscopic injection of 0.25mg/ml of ICG on 4 sites around gastric cancer * Identification of sentinel basin using fluorescence laparoscopy * Laparoscopic sentinel basin dissection and identification of sentinel node at the back table 2. Surgical considerations * Conventional gastrectomy is performed if positive sentinel nodes are diagnosed in the frozen section. * If micrometastasis or isolated tumor cells in sentinel basin lymph nodes were diagnosed in permanent pathology, re-operation of conventional gastrectomy is not performed. * However, re-operation of conventional gastrectomy should be performed in case of macrometastasis, deep and lateral margin positive, more than pT2 lesion in the permanent pathology.