NCT01242124Unknown2 期
Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Long and short outcome related with anastomoses
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
- •Received no previous treatment for esophageal cancer
- •Adequate bone marrow, liver and kidney function
- •Patients must be able to understand the nature consent of the study and give written informed consent.
排除标准
- •Age < 18 years
- •History of significant heart disease
- •Inoperable on the basis of co-existent medical problems
结局指标
主要结局
Long and short outcome related with anastomoses
时间窗: 3 year
Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.
次要结局
- Quality of life and function outcomes(3 year)
研究者
研究点 (1)
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