A Comparison of Short-term and Long- Term Outcomes Between Ivor-Lewis and McKeown Minimally Invasive Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Overall postoperative complications
研究概览
简要总结
Surgery is still the main treatment for esophageal cancer, however, the complication and mortality rate of open esophagectomy is high. As a result, the thoracoscopic- laparoscopic minimally invasive esophagectomy (MIE) was developed. The MIE mainly comprised two surgical approaches:
MIE McKeown approach (cervical anastomosis) and MIE Ivor-Lewis approach (intrathoracicanastomosis). The MIE with intrathoracic anastomosis (Ivor-Lewis) is increasingly used for the treatment of mid and lower esophageal cancers. Our study is trying to compare the safety, feasibility, and short-term and long- term outcomes between MIE Ivor-Lewis approach and MIE McKeown approach for the treatment of lower thoracic esophageal cancer and esophageal- gastric junction.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(I) Patients with clinically staged T1-3N0-2M0 tumors; good cardiopulmonary function;
- •(II) Patients with lower thoracic esophageal tumors and esophageal- gastric junction tumor;
- •(III) Patients without a previous history of cancer;
- •(IV) Patients without a previous history of neck or chest surgery;
排除标准
- •(I) cardiopulmonary function not good enough for surgery;
- •(II) Patients with hybrid MIE
研究组 & 干预措施
Ivor-Lewis group
minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
干预措施: MIE Ivor- Lewis (Procedure)
McKeown group
minimally invasive esophagectomy (MIE) with cervical anastomosis
干预措施: MIE McKeown (Procedure)
结局指标
主要结局
Overall postoperative complications
时间窗: within one month
Overall postoperative complication rates
次要结局
- progression-free survival(within 5 years)
- Operating time(1 day)
- Lymph nodes harvested(1 day)
- Blood loss(1 day)
- Anastomotic leak(within one month)
- Pulmonary complication(1 month)
- Anastomotic stenosis(within three months)
- recurrent laryngeal nerve injury(within three months)
- Chylothorax(within one month)
- Cardiac arrhythmia(within one month)
- Laboratory findings(within 3 days)
- Hospital stay(within 60 days)
- mortality(within 30 and 90 days)