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

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

University of Toronto / Toronto General Hospital, University of Florida, Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France), St Vincent's Hospital Melbourne, University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Melbourne / Barwon Health (Geelong, Australia)

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.

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

The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.

Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at weeks 3 and 7; months 6, 12, 18, 24; and years 3, 4, and 5, which coincide with the intervals of oncological surveillance.

Inclusion Criteria: 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. Exclusion Criteria: Clinical stage IIIb or IV NSCLC Not a candidate for minimally invasive surgery.

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