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Robotic vs Standard Keyhole Surgery for Early-Stage Lung Cancer: An Australian Randomised Controlled Trial (RAVAL)

Robotic vs Thoracoscopic Surgical Resection for Early-Stage Lung cancer: An Australian Randomised Controlled Trial (RAVAL)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000951550
Enrollment
180
Registered
2024-08-06
Start date
2024-08-26
Completion date
2027-08-02
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. 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. Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress. It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.

Interventions

Trial is evaluating Robotic surgery for resection of their early-stage lung cancer. Surgery will be performed by a qualified thoracic surgeon and the surgery will take up to 3 hours. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments robotically. The trial will be evaluating the short-term outcomes post-surgery (compared to VATS [Video-Assisted Thoracic Surgery] resection) such as length of surgery, complications, length o

Trial is evaluating Robotic surgery for resection of their early-stage lung cancer. Surgery will be performed by a qualified thoracic surgeon and the surgery will take up to 3 hours. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments robotically. The trial will be evaluating the short-term outcomes post-surgery (compared to VATS [Video-Assisted Thoracic Surgery] resection) such as length of surgery, complications, length of post operative hospitalisation, and will also evaluate quality of life post-surgery.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Age 18 years and above • Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC) • Candidates for minimally invasive pulmonary surgery, as determined by the operating surgeon.

Exclusion criteria

• Not a candidate for minimally invasive lobectomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026