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

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ClinicalTrials.gov Identifier: NCT02617186
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
University of Toronto / Toronto General Hospital
University of Florida
Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France)
Information provided by (Responsible Party):
Wael Hanna, McMaster University

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
Non-small Cell Lung Cancer Thoracic Surgery Procedure: Video-assisted thoracoscopic surgery Procedure: Robotic thoracic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 592 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial
Study Start Date : January 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2031

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Difference in HRQOL scores at week 12 between the treatment groups [ Time Frame: 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 :
  1. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Clinical staging will be determined from diagnostic imaging reports

  2. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Pathological staging will be determined from pathology report

  3. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Number of lymph nodes sampled

  4. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Admission date

  5. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Date of surgery

  6. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Discharge date

  7. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Chest tube removal date

  8. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Intraoperative blood loss

  9. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Post-operative analgesia will be determined from list of prescribed pain medications

  10. Short-term clinical outcome differences [ Time Frame: 3 weeks post-surgery ]
    Post-surgical pain will be determined from the Numeric Pain Rating Scale

  11. Resource utilization [ Time Frame: 1 year post-surgery ]
    Operating room time

  12. Resource utilization [ Time Frame: 1 year post-surgery ]
    Operating room staff

  13. Resource utilization [ Time Frame: 1 year post-surgery ]
    Surgical instruments and consumables

  14. Resource utilization [ Time Frame: 1 year post-surgery ]
    Admission to critical care beds

  15. Resource utilization [ Time Frame: 1 year post-surgery ]
    Hospital length of stay

  16. Resource utilization [ Time Frame: 1 year post-surgery ]
    Duration of intravenous analgesia

  17. Resource utilization [ Time Frame: 1 year post-surgery ]
    Postoperative complications

  18. Resource utilization [ Time Frame: 1 year post-surgery ]
    Costs associated with chronic post-surgical pain up to one year after surgery.

  19. Cost Effectiveness [ Time Frame: 5 years post-surgery ]
    The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.

  20. Difference in HRQOL scores between the treatment groups [ Time Frame: 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.

  21. Difference in 5-year survival rate between the two groups [ Time Frame: 5 years post-surgery ]
    Difference in 5-year survival rate between the two groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617186


Contacts
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Contact: Yogita S Patel 905-522-1155 ext 35096 patelys@mcmaster.ca

Locations
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Canada, Ontario
McMaster University / St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Yogita S Patel    905-522-1155 ext 35096    patelys@mcmaster.ca   
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
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Principal Investigator: Waël C Hanna, MDCM, MBA, FRCSC McMaster University
Publications:
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.
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.
Research Electronic Data Capture (RedCap). http://www.project-redcap.org
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wael Hanna, Associate Professor, Departments of Surgery and HEI, McMaster University
ClinicalTrials.gov Identifier: NCT02617186    
Other Study ID Numbers: BFCRS-RP-003-1508-31
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases