Robotic vs. Video-Assisted Thoracic Surgery for Early Stage Lung Cancer

Overseen By Yogita S Patel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: Stage IIIb or IV NSCLC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

592 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of robotic-assisted thoracic surgery for early-stage lung cancer?

Research shows that robotic-assisted thoracic surgery for early-stage lung cancer is safe and effective, with benefits like less pain after surgery, lower risk of death, and shorter hospital stays compared to video-assisted surgery. It also provides long-term results similar to traditional methods, making it a promising option for patients. ^{1 2 3 4 5}

Is robotic thoracic surgery safe for humans?

Robotic thoracic surgery, including robotic lobectomy, is generally considered safe for humans, with studies showing similar safety outcomes to video-assisted thoracic surgery (VATS). It offers benefits like shorter hospital stays and faster recovery, although its widespread adoption is still debated. ^{3 5 6 7 8}

How does robotic thoracic surgery differ from other treatments for early-stage lung cancer?

Robotic thoracic surgery is a minimally invasive treatment that uses robotic technology to assist surgeons in performing precise operations, potentially improving short-term outcomes and operative safety compared to traditional methods like video-assisted thoracic surgery (VATS) and thoracotomy. This approach may offer better lymph node dissection, which is important for accurate cancer staging and treatment. ^{2 3 9 10 11}

Research Team

Waël C Hanna, MDCM, MBA, FRCSC

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults over 18 with early-stage lung cancer (stage I, II or IIIa) who are candidates for minimally invasive lung surgery. It's not suitable for those with more advanced stage IIIb or IV cancer, or those who can't have minimally invasive procedures.

Inclusion Criteria

I am 18 years old or older.

My lung cancer is at an early to mid-stage (I, II, or IIIa).

My surgeon has approved me for a keyhole surgery on my lung.

Exclusion Criteria

I cannot have surgery with small incisions.

My lung cancer is in an advanced stage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Robotic Lobectomy or Thoracoscopic Lobectomy for early stage lung cancer

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, with HRQOL scores measured at various intervals

5 years

Multiple visits at 3, 7 weeks; 6 months; 1, 1.5, 2, 3, 4, 5 years post-surgery

Long-term follow-up

Participants are monitored for long-term outcomes including survival rates and cost-effectiveness

5 years

Treatment Details

Interventions

• Robotic thoracic surgery
• Video-assisted thoracoscopic surgery

Trial Overview The study compares two types of minimally invasive lung surgery: video-assisted thoracoscopic lobectomy (VATS) and robotic thoracic surgery (RTS). Patients will be randomly assigned to receive either VATS, which uses a camera and small incisions, or RTS, which employs precise instruments and 3D imaging.

Participant Groups

Group I: Thoracoscopic Lobectomy Active Control 1 Intervention

Group II: Robotic Lobectomy Active Control 1 Intervention

Robotic thoracic surgery is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Robotic-assisted thoracic surgery for:

• Early stage lung cancer
• Locally advanced NSCLC

Approved in Canada as Robotic lobectomy for:

• Early stage lung cancer

Approved in European Union as Robotic-assisted thoracic surgery for:

• Early stage lung cancer
• Locally advanced NSCLC

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

University Hospital, Rouen

Collaborator

Trials

412

Recruited

204,000+

University of Toronto / Toronto General Hospital

Collaborator

Trials

1

Recruited

590+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Rouen Normandy University / CHU-Hopitaux de Rouen (Rouen, France)

Collaborator

Trials

1

Recruited

590+

St Vincent's Hospital Melbourne

Collaborator

Trials

32

Recruited

6,500+

University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia)

Collaborator

Trials

1

Recruited

590+

University of Melbourne / Barwon Health (Geelong, Australia)

Collaborator

Trials

1

Recruited

590+

Findings from Research

Robotic-assisted thoracoscopic surgery (RATS) for early-stage lung cancer is safe, with similar postoperative morbidity rates compared to video-assisted thoracoscopic surgery (VATS) (20.2% vs 25.5%).

RATS showed a significantly lower recurrence rate (6.4%) compared to VATS (18.1%) during a median follow-up of 29 months, indicating better oncologic outcomes for patients undergoing robotic surgery, although overall survival and disease-free survival rates were similar between the two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operative outcomes and middle-term survival of robotic-assisted lung resection for clinical stage IA lung cancer compared with video-assisted thoracoscopic surgery. Forcada, C., Gómez-Hernández, MT., Rivas, C., et al.[2023]

In a study of 259 patients with clinical stage I non-small cell lung cancer, robotic-assisted thoracoscopic surgery (RATS) showed fewer minor complications compared to traditional thoracotomy (TL) and video-assisted thoracoscopic surgery (VATS), with rates of 34.4% for TL, 18.75% for VATS, and 8.57% for RATS.

While RATS had advantages in postoperative recovery metrics like ICU stay and hospitalization length, it also had longer operating times and higher costs, suggesting that VATS remains a more practical option for surgical treatment of stage I NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative outcomes, lymph node dissection and effects on costs among thoracotomy, video-assisted and robotic-assisted lobectomy for clinical stage I non-small cell lung cancer. Gullo, R., Gagliardo, CM., Palazzolo, M., et al.[2021]

Robotic lobectomy is a safe and effective surgical option for early-stage lung cancer, showing long-term results comparable to traditional methods like video-assisted thoracic surgery (VATS) and thoracotomy.

The technique is reproducible across multiple centers, and performing lymphadenectomy during the procedure may help improve the accuracy of staging lymph nodes, which is crucial for effective treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic lobectomy for non-small cell lung cancer: long-term oncologic results. Park, BJ.[2022]

The RAVAL trial is a large, prospective randomized controlled trial comparing robotic-assisted lobectomy to video-assisted lobectomy in 186 to 592 patients with early-stage non-small cell lung cancer, aiming to provide high-quality data on patient-reported health-related quality of life outcomes.

The trial will also assess cost-effectiveness and 5-year survival rates, addressing key barriers to the adoption of robotic surgery in thoracic procedures, such as perceived higher costs and lack of robust evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. Patel, YS., Hanna, WC., Fahim, C., et al.[2022]

Robotic lobectomy for stage I or II non-small cell lung cancer is safe and shows similar postoperative outcomes to video-assisted thoracoscopic surgery (VATS), with comparable 30-day mortality rates (0.6% for robotic vs. 0.8% for VATS).

Despite longer operative times for robotic lobectomy (median 186 minutes vs. 173 minutes for VATS), both techniques had similar rates of complications and nodal upstaging, indicating that robotic lobectomy can be an effective alternative to VATS, especially for patients with more comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Video-Assisted Thoracoscopic Surgery and Robotic Approaches for Clinical Stage I and Stage II Non-Small Cell Lung Cancer Using The Society of Thoracic Surgeons Database. Louie, BE., Wilson, JL., Kim, S., et al.[2022]

In a study of 18,908 stage I non-small cell lung cancer patients, those treated with robotic-assisted thoracoscopic surgical lobectomy (RATS-L) had a higher 90-day mortality rate (6.6%) compared to those who underwent video-assisted thoracoscopic surgical lobectomy (VATS-L) (3.8%), particularly if conversion to open thoracotomy occurred.

For patients with tumors 20 mm or smaller, RATS-L was associated with a significantly increased long-term mortality risk compared to VATS-L, with hazard ratios indicating a 33% higher risk after the first year post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients. Cui, Y., Grogan, EL., Deppen, SA., et al.[2022]

Minimally invasive pulmonary surgery, particularly through robotic-assisted techniques, offers significant benefits such as shorter hospital stays, faster recovery, reduced pain, and lower morbidity and mortality rates.

Despite the advantages, robotic surgery in thoracic procedures lacks standardization, particularly regarding the optimal docking approach, which can impact its implementation and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic lung resections: video-assisted thoracic surgery based approach. Toker, A., Kaba, E., Ayalp, K., et al.[2020]

Robotic lung resection showed similar clinical outcomes to video-assisted thoracoscopic surgery (VATS) in terms of tumor size, operative time, blood loss, and length of hospital stay, based on a comparison of 40 robotic and 35 VATS procedures.

Patients who underwent robotic surgery experienced less postoperative pain and returned to their usual activities faster than those who had VATS, suggesting a potential advantage of robotic techniques in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Louie, BE., Farivar, AS., Aye, RW., et al.[2022]

In a comparison of 28 video-assisted thoracoscopic surgery (VATS) lobectomies and 28 robotic lobectomies, both methods showed similar perioperative outcomes, including operative time and length of hospital stay, indicating that robotic surgery is as effective as traditional methods.

The robotic approach demonstrated enhanced safety, with a lower rate of emergency conversions for uncontrolled bleeding (1 in the robotic group vs. 4 in the VATS group), suggesting it may be a safer option for early-stage non-small cell lung cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Thoracoscopic Surgery versus Video-Assisted Thoracoscopic Surgery for Lung Lobectomy: Can a Robotic Approach Improve Short-Term Outcomes and Operative Safety? Mahieu, J., Rinieri, P., Bubenheim, M., et al.[2022]

A meta-analysis of 3379 patients found that robotic thoracic surgery (RTS) and video-assisted thoracic surgery (VATS) have similar rates of perioperative morbidity and mortality, indicating that RTS is a safe alternative to VATS for lung cancer resection.

The study suggests that while RTS shows comparable outcomes to VATS, further randomized studies are needed to explore its potential advantages and disadvantages in specific clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic thoracic surgery versus video-assisted thoracic surgery for lung cancer: a meta-analysis. Ye, X., Xie, L., Chen, G., et al.[2022]

In a study of 61 patients with early-stage lung cancer, robot-assisted video-assisted thoracic surgery lobectomy was performed successfully without any emergent conversions to traditional thoracotomy, indicating the procedure's feasibility.

At a mean follow-up of 28 months, all patients were alive with no local recurrence, although 4 patients developed distant metastases, suggesting that while the surgery is effective, further long-term evaluation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted thoracoscopic lobectomy for early-stage lung cancer. Gharagozloo, F., Margolis, M., Tempesta, B.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Operative outcomes and middle-term survival of robotic-assisted lung resection for clinical stage IA lung cancer compared with video-assisted thoracoscopic surgery. [2023]

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Postoperative outcomes, lymph node dissection and effects on costs among thoracotomy, video-assisted and robotic-assisted lobectomy for clinical stage I non-small cell lung cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Robotic lobectomy for non-small cell lung cancer: long-term oncologic results. [2022]

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RAVAL trial: Protocol of an international, multi-centered, blinded, randomized controlled trial comparing robotic-assisted versus video-assisted lobectomy for early-stage lung cancer. [2022]

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Comparison of Video-Assisted Thoracoscopic Surgery and Robotic Approaches for Clinical Stage I and Stage II Non-Small Cell Lung Cancer Using The Society of Thoracic Surgeons Database. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Mortality for Robotic- vs Video-Assisted Lobectomy-Treated Stage I Non-Small Cell Lung Cancer Patients. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Robotic lung resections: video-assisted thoracic surgery based approach. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Robot-Assisted Thoracoscopic Surgery versus Video-Assisted Thoracoscopic Surgery for Lung Lobectomy: Can a Robotic Approach Improve Short-Term Outcomes and Operative Safety? [2022]

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Robotic thoracic surgery versus video-assisted thoracic surgery for lung cancer: a meta-analysis. [2022]

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Robot-assisted thoracoscopic lobectomy for early-stage lung cancer. [2022]