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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of minimally invasive surgeries for early-stage lung cancer. One method uses video assistance (VATS), while the other employs robotic technology (RTS, also known as robotic thoracic surgery) for potentially greater precision and range of motion. The researchers aim to determine which option provides better quality of life and patient outcomes, as well as to evaluate the associated costs. The trial seeks participants with early-stage non-small cell lung cancer (NSCLC) who qualify for minimally invasive lung surgery.

As an unphased trial, this study allows patients to contribute to advancements in surgical techniques for lung cancer treatment.

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 prior data suggests that these surgical techniques are safe for early stage lung cancer?

Research has shown that both robotic thoracic surgery (RTS) and video-assisted thoracoscopic surgery (VATS) are generally safe for treating early-stage lung cancer. Studies have found that robotic surgery results are similar to those of VATS in terms of patient safety and recovery. Specifically, one study found that robotic surgery had fewer complications than VATS.

For VATS, research indicates it helps patients recover better compared to traditional open surgery. A combined analysis of several studies showed that VATS reduces the risk of death by 21% for lung cancer patients. Both RTS and VATS are considered minimally invasive, involving smaller cuts and usually leading to quicker recovery times.

In summary, both RTS and VATS are well-tolerated and have good safety records for lung cancer surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing robotic thoracic surgery and video-assisted thoracoscopic surgery (VATS) for early-stage lung cancer because these techniques offer potential benefits over traditional open surgery. Robotic surgery is unique because it provides surgeons with enhanced precision and control through robotic arms, possibly leading to less tissue damage and shorter recovery times. VATS, on the other hand, involves smaller incisions and potentially less postoperative pain compared to open surgery. By directly comparing these minimally invasive approaches, researchers aim to determine which method provides better outcomes for patients, helping to refine surgical options for early-stage lung cancer.

What evidence suggests that this trial's treatments could be effective for early stage lung cancer?

This trial will compare robotic thoracic surgery (RTS) and video-assisted thoracoscopic surgery (VATS) for early-stage lung cancer. Studies have shown that both RTS and VATS yield better results than traditional open surgery. Research indicates that RTS provides precise control and 3D imaging, enhancing the surgeon's view and movements. Previous findings suggest RTS has similar early outcomes to VATS, with a tendency for fewer complications. For VATS, studies highlight benefits such as quicker physical recovery and fewer complications during hospitalization. While both methods are effective, RTS may offer greater surgical precision, and VATS may lead to a faster recovery. ^{1 2 3 6 7}

Who Is on the Research Team?

Waël C Hanna, MDCM, MBA, FRCSC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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-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]

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]

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