Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Thoracoscopic Lobectomy
|
Procedure: Video-assisted thoracoscopic surgery
patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
|
| Active Comparator: Robotic Lobectomy
|
Procedure: Robotic thoracic surgery
patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
|
Outcome Measures
Primary Outcome Measures
- Difference in HRQOL scores at week 12 between the treatment groups [12 weeks post-surgery]
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.
Secondary Outcome Measures
- Short-term clinical outcome differences [3 weeks post-surgery]
Clinical staging will be determined from diagnostic imaging reports
- Short-term clinical outcome differences [3 weeks post-surgery]
Pathological staging will be determined from pathology report
- Short-term clinical outcome differences [3 weeks post-surgery]
Number of lymph nodes sampled
- Short-term clinical outcome differences [3 weeks post-surgery]
Admission date
- Short-term clinical outcome differences [3 weeks post-surgery]
Date of surgery
- Short-term clinical outcome differences [3 weeks post-surgery]
Discharge date
- Short-term clinical outcome differences [3 weeks post-surgery]
Chest tube removal date
- Short-term clinical outcome differences [3 weeks post-surgery]
Intraoperative blood loss
- Short-term clinical outcome differences [3 weeks post-surgery]
Post-operative analgesia will be determined from list of prescribed pain medications
- Short-term clinical outcome differences [3 weeks post-surgery]
Post-surgical pain will be determined from the Numeric Pain Rating Scale
- Resource utilization [1 year post-surgery]
Operating room time
- Resource utilization [1 year post-surgery]
Operating room staff
- Resource utilization [1 year post-surgery]
Surgical instruments and consumables
- Resource utilization [1 year post-surgery]
Admission to critical care beds
- Resource utilization [1 year post-surgery]
Hospital length of stay
- Resource utilization [1 year post-surgery]
Duration of intravenous analgesia
- Resource utilization [1 year post-surgery]
Postoperative complications
- Resource utilization [1 year post-surgery]
Costs associated with chronic post-surgical pain up to one year after surgery.
- Cost Effectiveness [5 years post-surgery]
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 [3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery]
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.
- Difference in 5-year survival rate between the two groups [5 years post-surgery]
Difference in 5-year survival rate between the two groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age >/= 18 years
-
Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
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Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.
Exclusion Criteria:
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Clinical stage IIIb or IV NSCLC
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Not a candidate for minimally invasive surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | McMaster University / St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
Sponsors and Collaborators
- St. Joseph's Healthcare Hamilton
- University of Toronto / Toronto General Hospital
- University of Florida
- Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France)
Investigators
- Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cerfolio RJ, Bryant AS. How to teach robotic pulmonary resection. Semin Thorac Cardiovasc Surg. 2013 Spring;25(1):76-82. doi: 10.1053/j.semtcvs.2013.01.004. Review.
- Cerfolio RJ. Total port approach for robotic lobectomy. Thorac Surg Clin. 2014 May;24(2):151-6, v. doi: 10.1016/j.thorsurg.2014.02.006. Review.
- D'Amico TA, Niland J, Mamet R, Zornosa C, Dexter EU, Onaitis MW. Efficacy of mediastinal lymph node dissection during lobectomy for lung cancer by thoracoscopy and thoracotomy. Ann Thorac Surg. 2011 Jul;92(1):226-31; discussion 231-2. doi: 10.1016/j.athoracsur.2011.03.134.
- EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208.
- Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007. Review.
- Hanna, WC., Fahim, C., Patel, P., Shargall, Y., Waddell TK., Yasufuku, K. (2015). Robotic Pulmonary Resection for Lung Cancer: The First Canadian Series. Abstract Accepted for podium presentation at Canadian Association of Thoracic Surgeons (CATS) 18th Annual Meeting, September 17-20, Quebec, QC.
- Kent M, Wang T, Whyte R, Curran T, Flores R, Gangadharan S. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014 Jan;97(1):236-42; discussion 242-4. doi: 10.1016/j.athoracsur.2013.07.117. Epub 2013 Oct 1.
- Little, R.J.A. and Rubin, D.B. (1987) Statistical Analysis with Missing Data. J. Wiley & Sons, New York.
- Louie BE, Farivar AS, Aye RW, Vallières E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.
- Merritt RE, Hoang CD, Shrager JB. Lymph node evaluation achieved by open lobectomy compared with thoracoscopic lobectomy for N0 lung cancer. Ann Thorac Surg. 2013 Oct;96(4):1171-1177. doi: 10.1016/j.athoracsur.2013.05.044. Epub 2013 Jul 31.
- Nasir BS, Bryant AS, Minnich DJ, Wei B, Cerfolio RJ. Performing robotic lobectomy and segmentectomy: cost, profitability, and outcomes. Ann Thorac Surg. 2014 Jul;98(1):203-8; discussion 208-9. doi: 10.1016/j.athoracsur.2014.02.051. Epub 2014 May 1.
- Onaitis MW, Petersen RP, Balderson SS, et al. Thoracoscopic Lobectomy Is a Safe and Versatile Procedure. Transactions of the Meeting of the American Surgical Association. 2006;124:86-91. doi:10.1097/01.sla.0000234892.79056.63.
- Park BJ, Melfi F, Mussi A, Maisonneuve P, Spaggiari L, Da Silva RK, Veronesi G. Robotic lobectomy for non-small cell lung cancer (NSCLC): long-term oncologic results. J Thorac Cardiovasc Surg. 2012 Feb;143(2):383-9. doi: 10.1016/j.jtcvs.2011.10.055. Epub 2011 Nov 20.
- Paul S, Jalbert J, Isaacs AJ, Altorki NK, Isom OW, Sedrakyan A. Comparative effectiveness of robotic-assisted vs thoracoscopic lobectomy. Chest. 2014 Dec;146(6):1505-1512. doi: 10.1378/chest.13-3032.
- Pickard AS, Neary MP, Cella D. Estimation of minimally important differences in EQ-5D utility and VAS scores in cancer. Health Qual Life Outcomes. 2007 Dec 21;5:70. Erratum in: Health Qual Life Outcomes. 2010;8:4.
- Research Electronic Data Capture (RedCap). http://www.project-redcap.org
- SAS Institute Inc., SAS 9.4 Help and Documentation, Cary, NC: SAS Institute Inc., 2000-2012.
- Veronesi G. Robotic thoracic surgery: technical considerations and learning curve for pulmonary resection. Thorac Surg Clin. 2014 May;24(2):135-41, v. doi: 10.1016/j.thorsurg.2014.02.009. Review.
- Wei B, D'Amico TA. Thoracoscopic versus robotic approaches: advantages and disadvantages. Thorac Surg Clin. 2014 May;24(2):177-88, vi. doi: 10.1016/j.thorsurg.2014.02.001. Review.
- BFCRS-RP-003-1508-31