Clinical Trial

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT

Active, Not Recruiting
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Summary
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2015-11-26; most recent amendment 2025-09-11.
Status change: Recruiting → Active, Not Recruiting 2025-09-11
Status change: Not Yet Recruiting → Recruiting 2016-01-19
Trial Details
NCT Number NCT02617186
Lead Sponsor St. Joseph's Healthcare Hamilton
Collaborators: University of Toronto, University of Florida, University Hospital, Rouen, St Vincent's Hospital Melbourne, University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Melbourne / Barwon Health (Geelong, Australia)
Conditions Non-small Cell Lung Cancer, Thoracic Surgery
Enrollment 446 participants
Start Date 2016-01
Primary Completion 2021-09 (estimated)
Study Completion 2031-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-12