The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Overall survival rate
研究概览
简要总结
Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
详细描述
Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.
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
- 35 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of esophageal cancer
- •Age between 35 to 75 years old
- •Resectable tumor as evaluation by preoperative imaging studies.
排除标准
- •Previous surgery in the chest or abdomen.
- •Receiving definitive chemoradiation (5500 cGy or more).
- •Tumor invasion to the trachea, spine or aorta.
- •Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
- •Previous history of cerebral vascular attack.
结局指标
主要结局
Overall survival rate
时间窗: 60 months
Overall survival rate of the participants after surgery
次要结局
- Ratio of ambulation(post-operative day 2 (POD2))
- Pain score as assessed by the face rating scale(1,7,14,28 days)
- Postoperative force vital capacity(1 and 3 months)
- Post operative forced expiratory volume in one second(1 and 3 months)
- Postoperative pulmonary complication(1 month)
