NCT02984787Unknown3 期
3D Versus 2D Laparoscopic Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
Chinese PLA General Hospital2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2017年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Number of splenic hilum lymph nodes harvested
研究概览
简要总结
The investigators will perform a prospective randomized comparison between 3D and 2D laparoscopic total gastrectomy with splenic hilum lymph nodes dissection.
详细描述
A prospective randomized comparison of 3D and 2D laparoscopic surgery for advanced gastric cancer with spleen-preserving splenic hilum lymph nodes dissection will be performed, to evaluate the safety and feasibility for the extensive application of the novel 3D laparoscopic technique. The evaluation parameters are number of group No.10 lymph nodes harvested, perioperative clinical efficacy, postoperative life quality and 3-year survival and recurrence rates.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- •cT2-4aN0-3M0 at preoperative evaluation according to AJCC Cancer Staging Manual, 7th Edition.
- •Eastern Cooperative Oncology Group (ECOG): 0 or 1;
- •American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
- •Written informed consent.
排除标准
- •Pregnant or breast-feeding women;
- •Severe mental disorder;
- •Previous upper abdominal surgery (except laparoscopic cholecystectomy);
- •Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
- •Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- •Other malignant disease within the past 5 years;
- •Previous neoadjuvant chemotherapy or radiotherapy;
- •Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
- •Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
结局指标
主要结局
Number of splenic hilum lymph nodes harvested
时间窗: 7 days
次要结局
- Early complication rate(30 days)
- Operative time(Intraoperative)
- Operative blood loss(Intraoperative)
- Time of splenic hilum lymph nodes dissection(Intraoperative)
- Number of total lymph nodes harvested(7 days)
- Poster-operative recovery course(30 days)
- Quality of life(1 year)
- 3-year disease free survival rate(3 years)
- 3-year overall survival rate(3 years)
研究者
Lin Chen
Deputy Director
Chinese PLA General Hospital
研究点 (2)
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