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

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-small Cell Lung Cancer, Thoracic Surgery

Intervention / Treatment
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* Procedure: Video-assisted thoracoscopic surgery
* Procedure: Robotic thoracic surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracoscopic Lobectomy<br> | Procedure: Video-assisted thoracoscopic surgery<br>* patients randomized to this arm will receive video-assisted thoracic surgery (VATS)<br>|
| Active Comparator: Robotic Lobectomy<br> | Procedure: Robotic thoracic surgery<br>* patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in HRQOL scores at week 12 between the treatment groups | Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12. | 12 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term clinical outcome differences | Clinical staging will be determined from diagnostic imaging reports | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Pathological staging will be determined from pathology report | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Number of lymph nodes sampled | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Admission date | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Date of surgery | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Discharge date | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Chest tube removal date | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Intraoperative blood loss | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Post-operative analgesia will be determined from list of prescribed pain medications | 3 weeks post-surgery | 
| Short-term clinical outcome differences | Post-surgical pain will be determined from the Numeric Pain Rating Scale | 3 weeks post-surgery | 
| Resource utilization | Operating room time | 1 year post-surgery | 
| Resource utilization | Operating room staff | 1 year post-surgery | 
| Resource utilization | Surgical instruments and consumables | 1 year post-surgery | 
| Resource utilization | Admission to critical care beds | 1 year post-surgery | 
| Resource utilization | Hospital length of stay | 1 year post-surgery | 
| Resource utilization | Duration of intravenous analgesia | 1 year post-surgery | 
| Resource utilization | Postoperative complications | 1 year post-surgery | 
| Resource utilization | Costs associated with chronic post-surgical pain up to one year after surgery. | 1 year post-surgery | 
| Cost Effectiveness | The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness. | 5 years post-surgery | 
| Difference in HRQOL scores between the treatment groups | 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. | 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery | 
| Difference in 5-year survival rate between the two groups | Difference in 5-year survival rate between the two groups. | 5 years post-surgery |