Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Rate of unsuccessful LND along the left RLN
研究概览
简要总结
The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.
详细描述
Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.
The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18~80
- •Histologically proven primary intrathoracic esophageal squamous cell carcinoma and will undergo McKeown MIE and bilateral RLN LND.
- •Patients should have a performance status 0, 1 or 2 according to the European Clinical Oncology Group.
- •Surgical resectable(cT1~4a, N0~3, M0)
- •Written informed consent
排除标准
- •Previous major thoracic surgery rendering minimal invasive approach unfeasible
- •prognosis determining malignancy other than esophageal cancer, inability to undergo curative resection and/or follow-up
- •inability to provide oral or written informed consent.
- •pre-existed vocal cord dysfunction will also be excluded.
结局指标
主要结局
Rate of unsuccessful LND along the left RLN
时间窗: Till 6 months postoperatively
Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \[i.e., recovering within 6 months\] versus permanent \[i.e. not recovering within 6 months\]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)
次要结局
- R0 resection rate(The pathological analysis will be finished within 2 weeks.)
- Rate of major postoperative complication(Duration of hospital stay, an expected average of 2~3 weeks)
- Blood loss during surgery(Day of surgery, up to 24 hours after surgery.)
- Length of postoperative hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks)
- In hospital, 30 day and 90 day mortality(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days)
- Length of intensive care unit stay after surgery(Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks)
- Overall survival rate(Assessed 24/36/60 months after surgery)
- The number of nodes removed along the right and left RLN(The pathological analysis will be finished within 2 weeks.)
- Operation time(thoracic phase)(Day of surgery)
- Rate of thoracotomy conversion(Day of surgery, up to 24 hours after surgery.)
- Re-entry ICU rate(Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks)
- Post esophagectomy pneumonia rate(Duration of hospital stay, an expected average of 2~3 weeks)
- Operation time(abdominal)(Day of surgery)
- Total operation time(Day of surgery)
- Unexpected events and complications occurring during surgery(Day of surgery, up to 24 hours after surgery.)
- Length of mechanical ventilator use after surgery(Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks)
- Re-intubation rate(Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks)
- Disease free survival rate(Assessed up to 24/36/60 months after surgery)
- Hospital Anxiety and Depression Scale (HADS)(pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.)
- European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18(pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively.)