NCT03524300招募中不适用
Prospective Randomized Controlled Trial for Comparison of Clinical Efficacy Between Robotic and Laparoscopic Total Gastrectomy in Patients With Clinical Stage I Gastric Cancer
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
The purpose of this study is to explore the clinical efficacy between robotic and laparoscopic total gastrectomy in patients with clinical Stage I gastric cancer
详细描述
Robotic surgery has been developed with the aim of improving surgical quality and overcoming the limitations of conventional laparoscopy in the performance of complex mini-invasive procedures. The study is designed to explore the clinical outcomes of the robotic assisted total gastrectomy by comparing short- and long-term outcomes including financial cost of robotic and laparoscopic assisted total gastrectomy in the treatment of clinical Stage I gastric adenocarcinoma （cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0））.
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 cStage IA（T1N0M0）or cStage IB（T1N1M0，T2N0M0）at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- •The tumor is on the upper or middle third stomach and expected to perform total gastrectomy with D1+/D2-10 lymph node dissction to obtain R0 resection sugicall results.
- •Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) class I to III
- •Written informed consent
排除标准
- •cStage IIA or more advaned at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •Multiple primary cancer
- •History of previous gastric surgery (except ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )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
- •FEV1<50% of the predicted values
结局指标
主要结局
3-year disease free survival rate
时间窗: 36 months
the rate of 3-year disease free survival
次要结局
- 3-year overall survival rate(36 months)
- Time to first flatus(30 days)
- operation time(1 day)
- 3-year recurrence pattern(36 months)
- Time to first liquid diet(30 days)
- intraoperative morbidity rates(1 day)
- overall postoperative serious morbidity rates(30 days)
- The variation of weight(3, 6, 9 and 12 months)
- overall postoperative morbidity rates(30 days)
- Time to first ambulation(30 days)
- Time to first soft diet(30 days)
- Duration of postoperative hospital stay(30 days)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Hospitalization expenses(30 days)
研究者
Chang-Ming Huang, Prof.
Director, Head of gastric surgery, Principal Investigator, Clinical Professor
Fujian Medical University
研究点 (1)
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