NCT05537129招募中不适用
A Prospective, Multicentral, Open-label, Randomized, Controlled Clinical Trial to Compare the Survival, Morbidity and Mortality of Laparoscopic and Open Total Gastrectomy for Gastric Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- 3 year-DFS
研究概览
简要总结
The aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.
详细描述
Gastric cancer is most common cause of cancer-related deaths in the world. Laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. With an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. However, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy)
- •age between 20 and 80 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •clinical stage I-III (T1-4aN0-2M0) according to the 8th edition of the Americal Joint Committee on Cancer System (Clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography)
- •scheduled for total gastrectomy with D2 lymphadenectomy, and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese
- •written informed consent
- •without preoperative chemotherapy and radiotherapy
排除标准
- •clinical stage T1-4N3M0 or T4bN0-3M0 according to the 8th edition of the Americal Joint Committee on Cancer System
- •history of chemotherapy, radiotherapy, immunotherapy or target therapy
- •perigastric lymphnode≥3cm
- •received gastric surgery (i.e. gastrectomy or gastrojejunostomy)
- •multiple primary tumors
- •suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases.
- •patients need emergency operation with complication of gastric cancer
- •adhesion due to the previous intraabdominal surgery
- •need for combined organ resection due to aggression of gastric cancer of other disease,
- •vulnerable people who cannot communicate or are pregnant (or planning to be pregnant)
- •currently participating or participated in other clinical trials in the last 6 months
结局指标
主要结局
3 year-DFS
时间窗: 3 year
3 year-disease free survival
次要结局
- morbidity and mortality rates(30 days following surgeries)
- 3 year-OS(3 year)
研究者
研究点 (1)
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