NCT02355249Unknown3 期
Traditional Three Incisions vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer: a Multi-center, Randomized, and Open-label Trial
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 648
- 试验地点
- 13
- 主要终点
- The incidence of respiratory complications
研究概览
简要总结
This study is a multi-center, randomized, and open-label trial to compare the safety and feasibility of traditional three incisions and minimally invasive thoracol-laparoscopic esophagectomy for esophageal 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
- •Histologic diagnosis of intrathoracic esophageal carcinoma of Stage I to III, which is potentially resectable judged by MDT
- •cT1b-4a，N0-2，M0 confirmed by chest CT, EUS, or EUS-FNA in four weeks;
- •ECOG PS scores≤2
- •Laboratory findings in 14 days before operation：normal blood test of basic metabolism panel
- •European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- •More than 12 months of expected survival
- •Tolerance of tracheal intubation and general anesthesia
- •Written informed consent
排除标准
- •Carcinoma of the cervical esophagus or gastro-esophageal junction (GEJ)
- •Prior thoracic surgery which may effect this study
- •Pregnant or breast feeding
- •Inability to tolerance of tracheal intubation and general anesthesia
- •unstable disease
- •Poor compliance
研究组 & 干预措施
A group (MIE)
Experimental
Via minimally invasive thoracol-laparoscopic esophagectomy.
干预措施: MIE (Procedure)
结局指标
主要结局
The incidence of respiratory complications
时间窗: 1 months
Respiratory complications including respiratory failure requiring mechanical ventilation, atelectasis needs suctioning of bronchoscopy, lung infection needs medication, adult respiratory distress syndrome.
次要结局
- Pain Scores after surgery(before operation, 1, 3 days and 1, 3, 6 months after surgery)
- Short-term Effects of Traditional Three Incisions Surgery vs Minimally Invasive Thoracol-laparoscopic Esophagectomy for Esophageal Cancer(2 years)
- lung function(before operation, 1, 3 months after surgery)
- The incidence of postoperative complications except respiratory complications(1 months)
- Health-related quality of life scores（HRQoL）(before operation, 1, 3, 6, 9, 12, 15,18, 21, 24 months after surgery)
研究者
Jie He
M.D. & Ph.D. , President of CICAMS
Chinese Academy of Medical Sciences
研究点 (13)
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