Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- rate of major postoperative complications
研究概览
简要总结
Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.
Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.
详细描述
This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with histologically proven esophageal malignancy
- •All patients were within the American Society of Anesthesiologists (ASA) class I to III
- •neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease
排除标准
- •Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax
结局指标
主要结局
rate of major postoperative complications
时间窗: 30 days after surgery
次要结局
- length of hospital stay(within 30 days after surgery)
- overall survival(3 years after surgery)
- rate of overall postoperative complications(30 days after surgery)
- operative time(during the operation)
- rate of 30-day mortality(30 days after surgery)
- rate of conversion(during the operation)
- disease-free survival(3 years after surgery)
- rate of R0 resection(within 30 days after surgery)
- number of harvested lymph nodes(within 30 days after surgery)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital