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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978882 on ClinicalTrials.gov