A Prospective, Multicenter, Randomized, Controlled Study of the Clinical Efficacy of Robotic and Laparoscopic Radical Total Gastrectomy in Locally Advanced Middle and Upper Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 570
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (CT2-4A, N-/+, M0) .
详细描述
In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for GC.
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
- •1.Age between 18 and 75 years 2.The primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR) by endoscopic biopsy.
- •3.Preoperative clinical stages were CT2-4A、 N-/+、and M0 (according to AJCC-8th TNM tumor staging) 4.Excepting to perform radical total gastrectomy and D2 lymph node dissection can achieve R0 resection.
- •5.American Society of Anesthesiology (ASA) score class I, II, or III 6.Written informed consent
排除标准
- •Preoperative examination suggested disease staging cT1, N-/+, and M0 (according to AJCC-8th TNM tumor staging )
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy(except for ESD/EMR for gastric cancer )
- •Enlarged or bulky regional lymph node over 3 cm by preoperative imaging
- •History of other malignant disease within the past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy)
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1 (forced expiratory volume in one second)<50% of predicted values
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
3-year disease free survival rate
次要结局
- 3-year overall survival rate(36 months)
- postoperative nutritional status(3, 6, 9 and 12 months)
- inflammatory immune response(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Morbidity rates(30 days)
- intraoperative morbidity rates(1 day)
- 3-year recurrence pattern(36 months)
- Total Number of Retrieved Lymph Nodes(1 day)
- postoperative recovery course(30 days)
- overall postoperative serious morbidity rates(30 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University Union Hospital