NCT03006263Enrolling By Invitation不适用
Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer
Fujian Medical University0 个研究点目标入组 110 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 110
- 主要终点
- overall postoperative morbidity rates
研究概览
简要总结
The purpose of this study is to explore clinical outcomes of totally laparoscopic versus laparoscopy assisted total gastrectomy for gastric cancer.
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 between 18 to 75 years old
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition）
- •No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- •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
- •Pregnant and lactating women
- •Suffering from severe mental disorder
- •History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- •History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- •Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging including enlarged or bulky No.10 lymph node
- •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
overall postoperative morbidity rates
时间窗: 30 days
Refers to the incidence of early postoperative complications. The early postoperative complication are defined as the event observed within 30 days after surgery.
次要结局
- 3-year disease free survival rate(36 months)
- Postoperative pain(30 days)
- The variation of cholesterol(3, 6, 9 and 12 months)
- The results of endoscopy(3 and 12 months)
- The variation of body temperature(8 days)
- 3-year recurrence pattern(36 months)
- Time to first ambulation(30 days)
- Time to first liquid diet(30 days)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Time to first soft diet(30 days)
- The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
- 3-year overall survival rate(36 months)
- Intraoperative morbidity rates(1 day)
- Time to first flatus(30 days)
- Duration of postoperative hospital stay(30 days)
- The variation of weight(3, 6, 9 and 12 months)
- The variation of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University
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