Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher
研究概览
简要总结
This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer.
If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
详细描述
Rationale: As stated in the 2010 revised Dutch esophageal carcinoma guidelines, the golden standard for surgical treatment of esophageal carcinoma is open transthoracic esophagectomy. Recent evidence suggests that robot-assisted thoraco-laparoscopic esophagectomy using the Da Vinci ® robot can provide an extensive resection, with possibly better or at least equal radical (R0) resection rates and an equal number of dissected lymph nodes. This is accompanied with markedly reduced blood loss and reduction of overall complications with shorter intensive care unit (ICU) and hospital stay. Therefore, the robot-assisted thoraco-laparoscopic esophagectomy is now at a stage that it should be compared to the current standard of care in a randomized controlled trial.
Objective: Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer.
Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age ≥ 18 and ≤ 75 jaar) with histologically proven surgically resectable (cT1-4a, N0-3, M0) squamous cell carcinoma, adenocarcinoma or undifferentiated esophageal carcinoma of the intrathoracic esophagus with European Clinical Oncology Group (ECOG) status 0, 1 or 2.
Intervention: 112 patients will be randomly allocated to either A) robot-assisted thoraco-laparoscopic esophagectomy (n=56) or B) open transthoracic esophagectomy (n=56).
Patients will receive the following interventions:
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 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, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
- •Surgical resectable (T1-4a, N0-3, M0)
- •Age ≥ 18 and ≤ 75 years
- •European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- •Written informed consent
排除标准
- •Carcinoma of the cervical esophagus
- •Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
- •Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection)
结局指标
主要结局
Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The primary outcome of this study is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications (MCDC)
次要结局
- Oncologic outcomes(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery.)
- Individual components of the primary endpoint (major and minor complications)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- (In hospital) Mortality within 30 and 60 days(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days)
- R0 resections (%)(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
- Operation related events(Day of surgery, up to 24 hours after surgery.)
- Quality of life(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery.)
- Costs (euro)(5 years follow up)
- Postoperative recovery(Participants will be followed for the duration of hospital stay, an expected average of 2 weeks)