Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Using Fluorescence (SENORITA4)
NCT05978882 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203
Last updated 2023-08-07
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.
Conditions
- Early Gastric Cancer
Interventions
- 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
Sponsors & Collaborators
-
Ajou University School of Medicine
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
Dongnam Institute of Radiological & Medical Sciences
collaborator OTHER -
Gyeongsang National University Hospital
collaborator OTHER -
Gyeongsang National University Changwon Hospital
collaborator OTHER -
Samsung Medical Center
collaborator OTHER -
Severance Hospital
collaborator OTHER -
Soon Chun Hyang University
collaborator OTHER -
National Cancer Center, Korea
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-17
- Primary Completion
- 2025-12-31
- Completion
- 2030-12-31
Countries
- South Korea
Study Locations
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