Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT
NCT ID: NCT02617186
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
446 participants
INTERVENTIONAL
2016-01-31
2031-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Thoracoscopic Lobectomy
Video-assisted thoracoscopic surgery
patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
Robotic Lobectomy
Robotic thoracic surgery
patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
Interventions
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Video-assisted thoracoscopic surgery
patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
Robotic thoracic surgery
patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
Eligibility Criteria
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Inclusion Criteria
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
2. Not a candidate for minimally invasive surgery.
18 Years
ALL
No
Sponsors
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University of Toronto / Toronto General Hospital
UNKNOWN
University of Florida
OTHER
University Hospital, Rouen
OTHER
St Vincent's Hospital Melbourne
OTHER
University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)
UNKNOWN
University of Melbourne / Barwon Health (Geelong, Australia)
UNKNOWN
St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Wael Hanna
Associate Professor, Departments of Surgery and HEI
Principal Investigators
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Waël C Hanna, MDCM, MBA, FRCSC
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University / St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
Louie BE, Farivar AS, Aye RW, Vallieres 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.
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.
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.
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.
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.
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.
Research Electronic Data Capture (RedCap). http://www.project-redcap.org
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.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
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. No abstract available.
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. doi: 10.1186/1477-7525-5-70.
Little, R.J.A. and Rubin, D.B. (1987) Statistical Analysis with Missing Data. J. Wiley & Sons, New York.
SAS Institute Inc., SAS 9.4 Help and Documentation, Cary, NC: SAS Institute Inc., 2000-2012.
Patel YS, Hanna WC, Fahim C, Shargall Y, Waddell TK, Yasufuku K, Machuca TN, Pipkin M, Baste JM, Xie F, Shiwcharan A, Foster G, Thabane L. RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. PLoS One. 2022 Feb 2;17(2):e0261767. doi: 10.1371/journal.pone.0261767. eCollection 2022.
Ujiie H, Gregor A, Yasufuku K. Minimally invasive surgical approaches for lung cancer. Expert Rev Respir Med. 2019 Jun;13(6):571-578. doi: 10.1080/17476348.2019.1610399. Epub 2019 May 6.
Other Identifiers
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BFCRS-RP-003-1508-31
Identifier Type: -
Identifier Source: org_study_id
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