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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617186
• Other study ID #: BFCRS-RP-003-1508-31
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2031

Study information

• Verified date: November 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Yogita S Patel
• Phone: 905-522-1155
• Email: patelys[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: September 2031
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer
• Thoracic Surgery

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Canada	McMaster University / St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (7)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France), St Vincent's Hospital Melbourne, University of Florida, University of Melbourne / Barwon Health (Geelong, Australia), University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Toronto / Toronto General Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

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