Robot-assisted Esophagectomy Versus Conventional Thoracoscopic Esophagectomy for Patients With Squamous Cell Esophageal Cancer: a Multicenter Open-label, Randomized Controlled Trial (RAMIE Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- Overall Survival Rate
研究概览
简要总结
This is the first randomized controlled study to compare the robot-assisted esophagectomy (RAE) to minimally invasive conventional thoracoscopic esophagectomy (CTE). The aim of this trial is to evaluate the safety, risks of the robot-assisted esophagectomy, and to compare the short-term operative outcomes and long-term oncological outcomes between the two surgical treatments.
详细描述
Objective: This study aims to compare the oncological outcomes between robot-assisted esophagectomy and minimally invasive conventional thoracoscopic esophagectomy.
Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age >= 18 and <= 75 years) with histologically proven surgically resectable (cT1b-3, N0-2, M0) squamous cell carcinoma of the intrathoracic esophagus with European Clinical Oncology Group performance status 0, 1 or 2.
Intervention: 360 patients will be randomly allocated to either A) robot-assisted esophagectomy (n=180) or B) conventional thoracoscopic esophagectomy (n=180).
Patients will receive the following interventions:
Group A. robot assisted esophagectomy, with gastric conduit formation. Group B. conventional thoracoscopic esophagectomy, with gastric conduit formation.
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
盲法说明
Open Label
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
- •Histologically proven squamous cell carcinoma of the intrathoracic esophagus.
- •Surgical resectable (T1b-3, N0-2, M0)
- •Age ≥ 18 and ≤ 75 years
- •European Clinical Oncology Group performance status 0, 1 or 2
- •Written informed consent
排除标准
- •Carcinoma of the cervical esophagus
- •Histologically proven adenocarcinoma or undifferentiated carcinoma.
- •Prior thoracic surgery at the right hemithorax or thorax trauma.
- •Infectious disease with systemic therapy indicated.
结局指标
主要结局
Overall Survival Rate
时间窗: 5 years
次要结局
- In hospital mortality(30-60 days after surgery)
- R0 resection (%)(within 30 days after surgery)
- Overall Survival Rate(3 years)
- Disease Free Survival Rate(5 years)
- Operative duration(during the operation, up to 5 hours)
- Postoperative recovery(from the date of surgery to the hospital discharge, assessed up to 15 days)
- Number of lymph nodes dissected(within 30 days after surgery)
- Estimated blood loss(during the operation, up to 5 hours)
- Quality of life(2 years)
- Postoperative major complications(30 days after surgery)
研究者
Zhigang Li
Chief
Shanghai Chest Hospital