Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
研究概览
简要总结
Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.
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
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females, aged≥20 years and ≤80 years
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
- •American Society of Anesthesiolosists (ASA) score of 1 to 3
- •Histologically confirmed adenocarcinoma in stomach
- •Clinical stage I (T1N0M0, T2N0M0, T1N1M0)
- •The patient has curatively resectable disease
- •The patient has given their written informed consent to participate in the study
排除标准
- •Experience of previous gastric resection
- •Complication due to gastric cancer, such as complete obstruction or perforation
- •History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
- •History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years
研究组 & 干预措施
NIR with ICG group
干预措施: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy (Procedure)
结局指标
主要结局
To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
时间窗: About 7 days after operation when pathologic result was reported
次要结局
未报告次要终点