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Purpose: To prove the feasibility of sentinel node navigation surgery (SNNS) in early gastric cancer patients with the risk of lymph node metastasis after endoscopic resection and preparation of multicenter phase 3 trial of stomach preserving surgery in these patients.
Contents: The number of enrollment is 247 patients. The patients underwent endoscopic resection for early gastric cancer, and the tumor was defined to be out of indication for endoscopic resection pathologically. So, additional gastrectomy is recommended for them.
The investigators will enroll patients who agree this study. After general anesthesia, Tc99m-Phytate with indocyanine green will be injected with endoscopy. Then sentinel basin will be detected using gamma probe and laparoscopic basin dissection will be done. Sentinel lymph node will be identify in back table dissection, and patients will undergo conventional gastrectomy. Detection rate and false negative rate will be evaluated by pathological review.
Sentinel basin dissection method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel basin dissection | Experimental | Intervention: Sentinel basin dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel basin dissection | Procedure | Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| detection rate (%) | number of patients whose sentinel nodes are detected / enrolled number of patients *100 | 15 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| False negative rate | number of patients without metastatic lymph node in sentinel basin / number of patients with metastatic lymph node *100 | 15 days after operation |
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Inclusion Criteria:
The expanded criteria for endoscopic resection are as follows
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bang Wool Eom, MD, PhD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bang Wool Eom | Goyang-si | Gyeonggi-do | 10408 | South Korea | ||
| Soonchunhyang University College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31245160 | Derived | Eom BW, Yoon HM, Min JS, Cho I, Park JH, Jung MR, Hur H, Kim YW, Park YK, Nam BH, Ryu KW; Sentinel Node Oriented Tailored Approach (SENORITA) Study Group. Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol. J Gastric Cancer. 2019 Jun;19(2):157-164. doi: 10.5230/jgc.2019.19.e12. Epub 2019 Apr 15. |
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| Bucheon-si |
| South Korea |
| Dongnam Institute of Radiological and Medical Science | Busan | South Korea |
| Gyeongsang National University Changwon Hospital | Changwon | South Korea |
| Kyungpook National University Medical Center | Daegu | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | South Korea |
| Gyeongsang National University Hospital | Jinju | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Ajou University School of Medicine | Suwon | 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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