Feasibility Study of Sentinel Navigation Surgery in Early Gastric Cancer Patients After Non-curative Endoscopic Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 10
- 主要终点
- detection rate (%)
研究概览
简要总结
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.
详细描述
Sentinel basin dissection method
- endoscopic tracer injection after general anesthesia
- Tracer : Tc99m-phytate 3cc and indocyanine green 3cc mix --> Injection of the probe (1cc/site, 4 sites) around endoscopic submucosal dissection ulcer scar
- Sentinel basin identification with laparoscopic probe
- Dissection of the sentinel basin
- Sentinel node dissection at back table
- Conventional laparoscopic gastrectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No limitation for age if the patient is available for gastrectomy
- •Patient who underwent endoscopic submucosal dissection and the tumor was defined as out of indication.
- •The expanded criteria for endoscopic resection are as follows
- •criterion I: intramucosal tumor without ulcerative findings and of differentiated type with size > 2 cm
- •criterion II: intramucosal tumor with ulcerative findings and of differentiated type with size ≤ 3 cm
- •criterion III: intramucosal tumor without ulcerative findings and of undifferentiated type with size < 2 cm
- •criterion IV, submucosal invasion < 500 mm and of differentiated type with size ≤ 3 cm)
- •Eastern Cooperative Oncology Group (ECOG) performance scale 0 or 1
排除标准
- •Inoperative due to severe cardiovascular or pulmonary disease
- •Patients who had previous gastric surgery
- •Patients who had previous upper abdomen surgery except cholecystectomy, or radiation therapy on upper abdomen, or hypersensitivity to any medicine
结局指标
主要结局
detection rate (%)
时间窗: 15 days after operation
number of patients whose sentinel nodes are detected / enrolled number of patients \*100
次要结局
- False negative rate(15 days after operation)
研究者
Bang Wool Eom
Staff surgeon
National Cancer Center, Korea