Randomized Controlled Trials on Clinical Outcomes of Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Morbidity rates
研究概览
简要总结
To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, 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 total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal 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
- •Age from over 18 to under 75 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- •expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •American Society of Anesthesiology (ASA) class I to III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
- •Gastric multiple primary carcinoma
- •Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
- •History of other malignant disease within the past 5 years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within the past 6 months
- •History of cerebrovascular accident within the past 6 months
- •History of continuous systematic administration of corticosteroids within 1 month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •Forced expiratory volume in 1 second (FEV1)<50% of the predicted values
结局指标
主要结局
Morbidity rates
时间窗: 30 days
This is for the early postoperative complication, which defined as the event observed within 30 days after surgery.
次要结局
- 3-year disease free survival rate(36 months)
- 3-year overall survival rate(36 months)
- 3-year recurrence pattern(36 months)
- intraoperative morbidity rates(1 day)
- overall postoperative serious morbidity rates(30 days)
- Total Number of Retrieved Lymph Nodes(1 day)
- postoperative recovery course(30 days)
- postoperative nutritional status(3, 6, 9 and 12 months)
- inflammatory immune response(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Time of digestive tract reconstruction(1 day)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University