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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02617186
Enrollment
446
Registered
2015-11-30
Start date
2016-01-31
Completion date
2031-09-30
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer, Thoracic Surgery

Brief 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.

Interventions

PROCEDUREVideo-assisted thoracoscopic surgery

patients randomized to this arm will receive video-assisted thoracic surgery (VATS)

PROCEDURERobotic thoracic surgery

patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot

Sponsors

University of Toronto / Toronto General Hospital
CollaboratorUNKNOWN
University of Florida
CollaboratorOTHER
University Hospital, Rouen
CollaboratorOTHER
St Vincent's Hospital Melbourne
CollaboratorOTHER
University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)
CollaboratorUNKNOWN
University of Melbourne / Barwon Health (Geelong, Australia)
CollaboratorUNKNOWN
St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \>/= 18 years 2. Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC) 3. Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.

Exclusion criteria

1. Clinical stage IIIb or IV NSCLC 2. Not a candidate for minimally invasive surgery.

Design outcomes

Primary

MeasureTime frameDescription
Difference in HRQOL scores at week 12 between the treatment groups12 weeks post-surgeryDifference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.

Secondary

MeasureTime frameDescription
Short-term clinical outcome differences3 weeks post-surgeryClinical staging will be determined from diagnostic imaging reports
Resource utilization1 year post-surgeryOperating room time
Cost Effectiveness5 years post-surgeryThe incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.
Difference in HRQOL scores between the treatment groups3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgeryDifference 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.
Difference in 5-year survival rate between the two groups5 years post-surgeryDifference in 5-year survival rate between the two groups.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026