Robotic Surgery for Lung Cancer

Overseen By Yogita S Patel, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Anticoagulants

Disqualifiers: Coagulopathy, Vascular disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of robotic surgery for individuals with early-stage non-small cell lung cancer (NSCLC). Totally Robotic Lung Resection allows the surgeon to perform the entire procedure using robotic tools, while Surgeon-Assisted Robotic Lung Resection involves the surgeon using handheld tools with robotic assistance. The trial aims to determine which method is more cost-effective and beneficial for patients. Suitable candidates have stage I, II, or IIIa NSCLC and qualify for robotic thoracoscopic surgery, a minimally invasive procedure with robotic assistance. As an unphased trial, it provides patients the chance to contribute to innovative surgical techniques that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are unable to stop anticoagulant therapy (blood thinners) before surgery.

What prior data suggests that robotic-assisted thoracoscopic surgery is safe for lung cancer patients?

Research has shown that robotic lung surgeries, like those in this study, are generally safe. Studies have found that these surgeries often lead to fewer complications and less blood loss. Patients typically spend less time in the hospital, indicating a smoother recovery.

For the Totally Robotic approach, data indicates it is well-tolerated, with low complication rates and successful outcomes in lung cancer surgeries. The tools used, such as robotic staplers and energy devices, are designed for precision and safety.

In summary, both robotic methods in this trial have safety records suggesting they are well-tolerated by patients. While every surgery carries risks, the evidence so far reassures those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic lung resections for lung cancer because they offer a high-tech approach to surgery that could enhance precision and recovery. Unlike traditional open or video-assisted thoracoscopic surgery (VATS), these robotic techniques use advanced tools like the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler, which can improve surgical precision and reduce human error. The totally robotic approach allows for less invasive procedures by fully utilizing robotic arms, potentially leading to quicker recovery times and less postoperative pain. Meanwhile, the surgeon-assisted approach combines robotic precision with a surgeon’s expertise, which might offer a balanced advantage of both human oversight and robotic accuracy. These innovations could significantly improve the surgical outcomes for lung cancer patients.

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

Research has shown that robotic lung surgery can improve recovery for patients with early-stage non-small cell lung cancer (NSCLC). This trial will compare two robotic surgery techniques: Totally Robotic Lung Resection and Surgeon-Assisted Robotic Lung Resection. Studies have found that robotic lobectomy, which involves removing part of the lung, often results in fewer postoperative complications than traditional methods. Patients who underwent robotic surgery generally had similar survival rates to those who had open or video-assisted surgeries. Additionally, robotic techniques may more effectively remove leftover cancer cells after tumor reduction. Overall, these findings suggest that robotic lung surgery is a promising option for NSCLC patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Waël C Hanna, MDCM MBA FRCSC

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

This trial is for patients with early-stage non-small cell lung cancer (NSCLC). Participants should be suitable candidates for robotic-assisted thoracoscopic surgery (RTS) but have not yet undergone the procedure. Specific eligibility criteria are not provided, so it's important to consult with the study team for detailed requirements.

Inclusion Criteria

My lung cancer is at an early to mid-stage.

My surgeon has approved me for reconstructive tissue surgery.

Ability to speak and understand English

Exclusion Criteria

I am not eligible for radiation therapy surgery.

I have a blood clotting disorder that cannot be cured.

I have a disease affecting my blood vessels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic-assisted thoracoscopic surgery (RTS) for early-stage non-small cell lung cancer (NSCLC) using either Totally Robotic or Surgeon-Assisted methods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for intraoperative complications, adverse events, and other clinical outcomes post-surgery

3 weeks

Multiple visits (in-person)

Cost Evaluation

Evaluation of surgical device costs and inpatient hospitalization costs

Up to 3 weeks following hospital discharge

What Are the Treatments Tested in This Trial?

Interventions

• Surgeon-Assisted Robotic Lung Resection
• Totally Robotic Lung Resection

Trial Overview The trial compares two methods of performing RTS: Totally Robotic lung resection using Vessel Sealer Extend and SureForm staplers versus Surgeon-Assisted resection using Medtronic Signia stapler. The goal is to assess differences in costs and patient outcomes between these techniques during NSCLC surgery.

How Is the Trial Designed?

Group I: Totally Robotic Experimental Treatment 1 Intervention

Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Group II: Surgeon-Assisted Active Control 1 Intervention

Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10636448/

Outcomes of robotic lobectomy for non-small cell lung ... RL for NSCLC performed in an NCI-CCC appears to have improved perioperative outcomes with comparable long-term OS compared to national benchmarks in OL and VL.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10814225/

Comparison of Robotic and Open Lobectomy for Lung Cancer ... The objective of this study was to evaluate the impact of the robotic technique on the postoperative outcomes of patients with poor lung ...

3. jtd.amegroups.org jtd.amegroups.org/article/view/78792/html

Long-term outcomes of robotic versus video-assisted ... Long-term outcomes of robotic versus video-assisted pulmonary lobectomy for non-small cell lung cancer: systematic review and meta-analysis ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666676624000127

A dual approach to lung cancer management In this way, it is more favorable to eliminate the rest of the cancer cells after the robotic surgery has reduced the size of the tumor and brought the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.15500

Uniportal Robotic Lobectomy and Lymphadenectomy for ... The clinical data of 34 consecutive patients with lung cancer who underwent improved uniportal robotic-assisted thoracoscopic surgery (uRATS) at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5896345/

The long-term survival of robotic lobectomy for non-small cell ... The latter has been shown to be safe and effective for pulmonary lobectomy for lung cancer with intraoperative and short-term postoperative metrics such as ...

7. ccts.amegroups.org ccts.amegroups.org/article/view/84092/html

Robotic anatomic pulmonary resection—the data - Watkins Existing data suggest that RL offers numerous advantages, such as reduced complications, minimal blood loss, shorter hospital stays, and lower ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772993123002863

The Safety of Robotic Pneumonectomy Robot-assisted pneumonectomy can be performed safely in the setting of appropriate oncologic indications. Patients have comparable rates of R0 resection, nodal ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818246

Video-Assisted vs Robotic-Assisted Lung Lobectomies for ... This cohort study of 1088 patients aged 18 to 90 years found that the median robotic-assisted adjusted operative duration was 20.6 minutes longer than that for ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1556086419306665

A Brief Report on Survival After Robotic Lobectomy for ... The 5-year recurrence of disease risk and overall survival were 24.9% and 83.2%, respectively, in the open group and 24.6% and 86.1%, respectively, in the ...