Early Gastric Cancer
Conditions
Keywords
Early gastric cancer, Sentinel lymph node, Fluorescence, Stomach-preserving surgery, Quality of life
Brief 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.
Interventions
PROCEDURELaparoscopic sentinel navigation surgery using fluorescence
If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed
Sponsors
Ajou University School of Medicine
Chonnam National University Hospital
Dongnam Institute of Radiological & Medical Sciences
Gyeongsang National University Hospital
Gyeongsang National University Changwon Hospital
Samsung Medical Center
Severance Hospital
Soon Chun Hyang University
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * ECOG 0 or 1 * patient who signed the agreement * patient who is suspected to underwent laparoscopic or robotic gastrectomy
Exclusion criteria
* 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 * diagnosed as malignancy within 5 years except carcinoma in situ of cervix cancer and thyroid cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of Sentinel lymph nodes | 15 days after operation | number of patients whose sentinel nodes are detected / enrolled number of patients \*100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3 year overall survival rate | 3 year after surgery | 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 | 3 year after surgery | 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 | 3 year after surgery | A total of enrollment period is suspected to be three years and patients will be followed up for five years. |
| scores of global health status scale, functional scales, and symptom scales/items of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22 | 5 years | Survey for quality of life will be performed regularly for three years after surgery. Measurement tool is the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and STO22. In EORTC QLQ C30, there are 1 global health status scale, 5 functional scales, and 9 symptom scales/items. EORTC QLQ STO22 includes 5 symptom scales and 4 single items. Each scale and item ranges 0 to 100. Higher score of global health status and functinoal scales indicate better quality of life and lower score of symptom scales indicates better quality of life. There is no summed score in these questionnaires. |
| 3 year disease free survival | 3 year after surgery | A total of enrollment period is suspected to be three years and patients will be followed up for five years. |
| 5 year overall survival rate | 5 years | A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention |
| 5 year disease specific death rate | 5 years | A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention |
| 5 year recurrence free survival rate | 5 years | A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention |
| 5 year disease free survival rate | 5 years | A total of enrollment period is suspected to be three years and patients will be followed up for five years. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention |
Countries
South Korea
Contacts
Primary ContactHong Man Yoon, MD
Outcome results
None listed