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

Early Gastric Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05978882
Study type Interventional
Source National Cancer Center, Korea
Contact Hong Man Yoon, MD
Phone +82-31-920-1710
Email red10000@ncc.re.kr
Status Not yet recruiting
Phase N/A
Start date August 17, 2023
Completion date December 31, 2030
View Details
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