NCT05978882

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic sentinel navigation surgery using fluorescence	If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed

Timeline

• Start date: 2023-08-17
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2023-08-07
• Last updated: 2023-08-07

Locations

7 sites across 1 country: South Korea