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Trial record 17 of 30 for:    10109801 [PUBMED-IDS]

Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer

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ClinicalTrials.gov Identifier: NCT02617186
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Toronto General Hospital
Information provided by (Responsible Party):
Wael Hanna, St. Joseph's Healthcare Hamilton

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 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 : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12 weeks. [ Time Frame: Assessed at 12 weeks, presented average 1 year from end of study ]


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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 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
Contact: Lisa L Patterson, BA 905-522-1155 patterls@stjoes.ca
Contact: Christine Fahim, PhD(c) 905-522-1155 tfahim@stjosham.on.ca

Locations
Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Lisa Patterson, BA    905-522-1155 ext 35096    pattersl@stjoes.ca   
Toronto General - University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Jennifer Lister       jennifer.lister@uhn.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Toronto General Hospital
Investigators
Principal Investigator: Waël C. Hanna, MDCM, MBA, FRCSC St. Joseph's Healthcare Hamilton / 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.

Responsible Party: Wael Hanna, Director, Research Program, Boris Family Centre for Robotic Surgery, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02617186     History of Changes
Other Study ID Numbers: BFCRS-RP-003-1508-31
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms