NCT01504997Unknown2 期
A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- The Incidence of Post-operative Intra-abdominal Infectious Complications
研究概览
简要总结
The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy specimen from the primary lesion shows adenocarcinoma
- •Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
- •Endoscopic submucosal dissection is not indicated
- •Tumor was located within lower two thirds of stomach
- •Not having duodenal invasion
- •Eastern clinical oncology group performance status is 0 or 1
- •Body mass index is lower than 30
- •No prior laparotomy
- •No prior chemotherapy or radiation including those for other cancers
- •Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl
排除标准
- •Having other active cancers
- •Possibly pregnant, or breast feeding woman
- •with psychiatric disorder
- •Receiving steroids
- •With Acute myocardial infarction in 6 months or with unstable angina
- •With uncontrolled hypertension
- •With uncontrolled diabetes mellitus
- •With pulmonary disease which require continuous oxygen therapy
结局指标
主要结局
The Incidence of Post-operative Intra-abdominal Infectious Complications
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 10 days
次要结局
- Relapse Free Survival(5 years)
- Incidence of Adverse Events(Participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Overall Survival(5 years)
- Completion Rate of Robot Assisted Surgery(During the surgery, an expected average of 5 hours)
研究者
Masanori Terashima
Head of Gastric Surgery
Shizuoka Cancer Center
研究点 (2)
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