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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer; Thoracic Surgery
• Intervention / Treatment: Procedure: Video-assisted thoracoscopic surgery; Procedure: Robotic thoracic surgery

• Study Type: Interventional
• Enrollment (Anticipated): 592
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yogita S Patel; Phone Number: 35096 905-522-1155; Email: patelys@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • McMaster University / St. Joseph's Healthcare Hamilton
      • Contact: Yogita S Patel; Phone Number: 35096 905-522-1155; Email: patelys@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: University of Florida; St Vincent's Hospital Melbourne; University of Toronto / Toronto General Hospital; Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France); University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia); University of Melbourne / Barwon Health (Geelong, Australia)
• Investigators: Principal Investigator: Wael C Hanna, MDCM, MBA, FRCSC, McMaster University

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Health Qual Life Outcomes. 2010;8:4.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2031

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: November 26, 2015
• First Posted (ESTIMATE): November 30, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: BFCRS-RP-003-1508-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO