NCT04010006Unknown不适用
Randomized Controlled Trials Comparing Clinical Outcome of HD Versus 4K Laparoscopy for Gastric Cancer(FUGES-017)
Fujian Medical University1 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2019年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- operating time
研究概览
简要总结
The purpose of this study is to explore the feasibility of 4K Laparoscopic Surgery for Gastric Cancer.
详细描述
A prospective randomized comparison of HD and 4K laparoscopic surgery for gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the 4K laparoscopic technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function 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
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)Age from over 19 to under 74 years
- •(2)cT 1-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •(3)Heart, lungs, kidneys and other vital organs function well, with no obvious surgical contraindications
- •(4)Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
- •(5)American Society of Anesthesiology (ASA) score class I, II, or III
- •(6)Written informed consent
排除标准
- •(1)Women during pregnancy or breast-feeding
- •(2)Severe mental disorder
- •(3)History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •(4)Enlarged splenic hilar lymph nodes with integration into a mass and surrounding the blood vessels
- •(5)History of unstable angina or myocardial infarction within past six months
- •(6)History of cerebrovascular accident within past six months
- •(7)History of continuous systematic administration of corticosteroids within one month
- •(8)History of previous neoadjuvant chemotherapy or radiotherapy
- •(9)T4b tumors
- •(10)Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •(11)FEV1(Forced expiratory volume in one second)#50% of predicted values
结局指标
主要结局
operating time
时间窗: 1 day
day
次要结局
- Time to first soft diet(10 days)
- intracavitary anastomosis time(1 day)
- the number of positive lymph nodes(1 day)
- intraoperative lymph node dissection time(1 day)
- intraoperative blood loss(1 day)
- the amount of use of titanium clip(1 day)
- duration of postoperative hospital stay(10 days)
- 3-year overall survival rate(36 months)
- Time to first ambulation(10 days)
- Time to first flatus(10 days)
- Complication(30 days;36 months)
- The number of lymph node dissection(1 day)
- intraoperative injury(1 day)
- Hospitalization expenses(1 months)
- Time to first liquid diet(10 days)
- the rate of conversion to laparotomy(1 day)
- The daily highest body temperature before discharge(7 days)
- Overall postoperative morbidity and mortality rates(30 days)
- 3-year disease free survival rate(36 months)
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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