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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 592 to confirmed 446
    • Site details revised
    v13
  2. Minor 2 versions Re-verified since Nov 21, 2023, no change to tracked fieldsv11-v12
  3. Minor Collaborators: 3 to 6v10
  4. Minor Re-verified, no change to tracked fieldsv9
  5. Notable Enrollment target: 186 to 592v8 Show 8 more changesShow less
    • Primary endpoint revised
    • Study sites: 2 to 1
    • Primary completion date: Jan 2022 to Sep 2021
    • Study completion date: Jan 2022 to Sep 2031
    • Secondary endpoints expanded, about 75 words
    • Collaborators: 1 to 3
    • Eligibility criteria expanded, about 1 word
    • Study title expanded, about 1 word
Show 6 earlier versionsHide 6 earlier versions
  1. Notable Primary completion date: Jan 2020 to Jan 2022
    • Study completion date: Jan 2021 to Jan 2022
    v7
  2. Notable Primary completion date: Jan 2018 to Jan 2020
    • Study completion date: Mar 2018 to Jan 2021
    v6
  3. Minor Study sites: 1 to 2v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02617186
Lead Sponsor St. Joseph's Healthcare Hamilton
Collaborators: University of Toronto, University of Florida, University Hospital, Rouen, St Vincent's Hospital Melbourne, University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Melbourne / Barwon Health (Geelong, Australia)
Conditions
(from sponsor)
Non-small Cell Lung Cancer, Thoracic Surgery
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 446 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov