跳至主要内容
临床试验/NCT02617186
NCT02617186进行中(未招募)不适用

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial

St. Joseph's Healthcare Hamilton2 个研究点 分布在 1 个国家目标入组 446 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
446
试验地点
2
主要终点
Difference in HRQOL scores at week 12 between the treatment groups

研究概览

简要总结

During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.

There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.

Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >/= 18 years
  • Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
  • Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

排除标准

  • Clinical stage IIIb or IV NSCLC
  • Not a candidate for minimally invasive surgery.

结局指标

主要结局

Difference in HRQOL scores at week 12 between the treatment groups

时间窗: 12 weeks post-surgery

Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.

次要结局

  • Resource utilization(1 year post-surgery)
  • Difference in 5-year survival rate between the two groups(5 years post-surgery)
  • Cost Effectiveness(5 years post-surgery)
  • Difference in HRQOL scores between the treatment groups(3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery)
  • Short-term clinical outcome differences(3 weeks post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wael Hanna

Associate Professor, Departments of Surgery and HEI

McMaster University

研究点 (2)

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