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| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
| Chonnam National University Hospital | OTHER |
| Dongnam Institute of Radiological & Medical Sciences | OTHER |
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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.
Injection of Indocyanine Green (ICG)
Surgical considerations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic sentinel navigation surgery | Experimental | compare the detection rate of sentinel lymph nodes to that of previous study (SENORITA1 trial) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic sentinel navigation surgery using fluorescence | Procedure | If the frozen biopsy of sentinel lymph nodes are all negative using fluorescence, stomach-preserving surgery is performed |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of Sentinel lymph nodes | number of patients whose sentinel nodes are detected / enrolled number of patients *100 | 15 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 after surgery |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Man Yoon, MD | Contact | +82-31-920-1710 | red10000@ncc.re.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongnam Inst. of Radiological & Medical Science | Busan | Gijang-gun | 46033 | South Korea | ||
| Gyeongsang National University Hospital |
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| Gyeongsang National University Hospital |
| OTHER |
| Gyeongsang National University Changwon Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Severance Hospital | OTHER |
| Soon Chun Hyang University | OTHER |
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| 3 year after surgery |
| 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 after surgery |
| 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. | 3 year after surgery |
| 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 | 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. | 5 years |
| 5 year disease free survival rate | 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 years |
| 5 year overall survival rate | 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 years |
| 5 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. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention | 5 years |
| 5 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. Therefore, we can complete data collection at five year later from when the last enrolled patients underwent intervention | 5 years |
| Gyeongsang |
| Gingu-si |
| 52727 |
| South Korea |
| Sevrance Hospital | Seoul | Sinchon | 03722 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | Suwon-si | 16499 | South Korea |
| Gyeongsang National University Changwon Hospital | Changwon | 51472 | South Korea |
| Samsung Medical Center | Seoul | South Korea |
|
| Soon Chun Hyang University Hospital Bucheon | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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