About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
single lesion of adenocarcinoma in preoperative endoscopic biopsy clinical stage T1N0 in the preoperative evaluation of endoscopy and computed tomography
tumor size: less than 3cm
location: 2cm far from the pylorus or cardia
aged 20 to 80
Disqualifiers
indication of endoscopic submucosal resection
inoperable due to poor cardiac, and pulmonary function
pregnant
having allergic reaction, previous upper abdominal surgery except laparoscopic cholecystectomy, previous radiation therapy to upper abdomen
Trial design
Single group
Treatments tested in this trial
Laparoscopic sentinel navigation surgery using fluorescence
Procedure/SurgeryIf the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
Treatment groups
Trial outcomes
Primary outcomes
Detection rate of Sentinel lymph nodes
number of patients whose sentinel nodes are detected / enrolled number of patients \*100
Secondary outcomes
3 year disease free survival
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year overall survival rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year disease specific death rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
3 year recurrence free survival rate
A total of enrollment period is suspected to be three years and patients will be followed up for five years.
Sponsors and contacts
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National Cancer Center, Korea
Lead sponsor
Ajou University School of Medicine
Collaborator
Chonnam National University Hospital
Collaborator
Dongnam Institute of Radiological & Medical Sciences
Collaborator
Gyeongsang National University Hospital
Collaborator
Gyeongsang National University Changwon Hospital
Collaborator
Samsung Medical Center
Collaborator
Severance Hospital
Collaborator
Soon Chun Hyang University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: