Minimally Invasive Esophagectomy (MIE): A Multicenter Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 81
- 主要终点
- Peri-operative Mortality at 30 Days
研究概览
简要总结
RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of performing minimally invasive esophagectomy (MIE), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage I-III esophageal cancer.
- Determine the complications associated with this procedure in these patients.
- Determine the rate at which conversion to open operation is required in patients undergoing this procedure.
- Determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure.
- Determine feasibility and conversion rate of MIE after neoadjuvant therapy.
- Assess the effectiveness of lymph node dissection by MIE by recording the total number of lymph nodes dissected.
- Assess outcomes at follow-up to three years.
OUTLINE: This is a multicenter study.
Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Peri-operative Mortality at 30 Days
时间窗: Assessed at 30 days from surgery
The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.
次要结局
- Total Number of Lymph Nodes Dissected(Assessed at surgery)
- Overall Length of Hospital Stay(Assessed after surgery until patients are out of hospital)
- 3-year Survival Rate(Assessed at 3 years)
- Duration of Operating Time(Assessed at surgery)
- Duration of Intensive Care Stay(Assessed after surgery until patients are out of intensive care)
- Rate of Conversion to Open Operation(Assessed at surgery)
- 30-day Peri-operative Mortality After Neoadjuvant Therapy(Assessed at 30 days after surgery)
- Rate of Conversion to Open Operation After Neoadjuvant Therapy(Assessed at surgery)