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

NCT02617186 | Active Not Recruiting

• 1 other identifier: BFCRS-RP-003-1508-31
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Short-term clinical outcome differences

  3 weeks post-surgery

• Short-term clinical outcome differences

  3 weeks post-surgery

• Short-term clinical outcome differences

  3 weeks post-surgery

• Short-term clinical outcome differences

  3 weeks post-surgery

• Short-term clinical outcome differences

  3 weeks post-surgery

Study Arms (2)

Thoracoscopic Lobectomy

ACTIVE COMPARATOR

Procedure: Video-assisted thoracoscopic surgery

Robotic Lobectomy

ACTIVE COMPARATOR

Procedure: Robotic thoracic surgery

Interventions

Video-assisted thoracoscopic surgery PROCEDURE

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

Thoracoscopic Lobectomy

Robotic thoracic surgery PROCEDURE

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

Robotic Lobectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• University of Toronto / Toronto General Hospital: collaborator
• University of Florida: collaborator
• University Hospital, Rouen: collaborator
• St Vincent's Hospital Melbourne: collaborator
• University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia): collaborator
• University of Melbourne / Barwon Health (Geelong, Australia): collaborator

Study Sites (1)

McMaster University / St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (21)

• 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.

  PMID: 18831499 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 24780416 BACKGROUND

• 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.

  PMID: 24793685 BACKGROUND

• 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.

  PMID: 22104677 BACKGROUND

• 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.

  PMID: 24780422 BACKGROUND

• 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.

  PMID: 22440364 BACKGROUND

• 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.

  PMID: 24090577 BACKGROUND

• 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.

  PMID: 24810546 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23915591 BACKGROUND

• 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.

  PMID: 21718849 BACKGROUND

• Research Electronic Data Capture (RedCap). http://www.project-redcap.org

  BACKGROUND

• 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.

  PMID: 24780418 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

• 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.

  PMID: 23800532 BACKGROUND

• 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.

  PMID: 18154669 BACKGROUND

• Little, R.J.A. and Rubin, D.B. (1987) Statistical Analysis with Missing Data. J. Wiley & Sons, New York.

  BACKGROUND

• SAS Institute Inc., SAS 9.4 Help and Documentation, Cary, NC: SAS Institute Inc., 2000-2012.

  BACKGROUND

• 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.

  PMID: 35108265 DERIVED

• 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.

  PMID: 31055977 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Waël C Hanna, MDCM, MBA, FRCSC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Departments of Surgery and HEI

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: November 30, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2021
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)