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
- 41
- 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
- •DISEASE CHARACTERISTICS:
- •High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded).
- •Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy.
- •Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration
- •Stomach must be available for conduit
- •Age of 18 and over
- •ECOG performance status of 0-2
- •Creatinine less than 2 mg/dL
- •Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed.
- •The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include:
- •Endoscopic ultrasound (EUS)
- •Positron emission tomography (PET) scan and/or laparoscopic staging (Laparoscopic staging could be performed on the day of resection. Additional evaluation was recommended if the PET scan suggested distant metastatic disease.)
排除标准
- •Cancer extending into the stomach more than 20%
- •Prior anti-reflux or gastric operations
- •Prior right thoracotomy
- •Prior major neck operation other than the removal of superficial skin lesion
研究组 & 干预措施
Minimally invasive esophagectomy (MIE)
Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.
干预措施: Minimally invasive esophagectomy (MIE) (Procedure)
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)