A Phase II Clinical Trial of Reduced Port Totally Laparoscopic Distal Gastrectomy With D2 Lymph Node Dissection for Gastric Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 67
- 主要终点
- Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
研究概览
简要总结
The purpose of this study is to determine if reduced port totally laparoscopic distal gastrectomy with complete D2 lymph node dissection for gastric cancer is safe and oncological feasible.
67 patients with gastric cancer with preoperative staging from T1 to T3 will undergo reduced port totally laparoscopic distal gastrectomy.
The primary end point of this study is to measure compliance rate with pathology report and compare with previous compliance rate data.
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
- •histologically confirmed adenocarcinoma of the stomach
- •Eastern Cooperative Oncology Group Eastern Cooperative Oncology Group performance status 0-1,
- •signed informed consent
- •location of the primary tumor in the antrum, angle and lower body
- •no evidence of distant metastasis or invasion to adjacent organs or serosal infiltration
排除标准
- •metastatic disease
- •previous history of malignancy in any organ
- •any co-morbidity obviating major surgery
结局指标
主要结局
Compliance rate (Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping)
时间窗: 1 month after enrollment of the patients
Compliance rate : Cases with no more than one missing lymph node station according to the Japanese Research Society of Gastric Cancer (JRSGC) lymph node grouping
次要结局
未报告次要终点