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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels \<7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.

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 data supports the effectiveness of the treatment Surgeon-Assisted Robotic Lung Resection, Totally Robotic Lung Resection for lung cancer?

Research shows that robotic lung surgery can be performed safely with low rates of complications and death. In one study, 80% of patients with early-stage lung cancer were alive without the disease coming back after robotic surgery, suggesting it can be effective for treating lung cancer. ^{1 2 3 4 5}

Is robotic lung surgery safe for humans?

Robotic lung surgery, including procedures like totally robotic lung resection, has been performed with low mortality and morbidity rates, indicating it is generally safe. Studies show that advanced thoracic procedures can be safely done using robotic systems, with a low rate of complications and conversions to traditional surgery. ^{1 2 6 7 8}

How is the treatment 'Surgeon-Assisted Robotic Lung Resection, Totally Robotic Lung Resection' different from other treatments for lung cancer?

This treatment is unique because it uses robotic technology to perform lung surgery with greater precision and less invasiveness compared to traditional methods. The robotic system allows for better visualization and manipulation of tissues, making it particularly useful for complex lung cancer surgeries and potentially leading to improved surgical outcomes. ^{1 2 5 9 10}

Research Team

Waël C Hanna, MDCM MBA FRCSC

Principal Investigator

St. Joseph's Healthcare Hamilton

Eligibility Criteria

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 disease affecting my blood vessels.

I have a blood clotting disorder that cannot be cured.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Robotic thoracic surgery for non-small cell lung cancer: initial experience in Brazil. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Robot-assisted lung resection: outcomes and technical details. [2022]

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

Early experience with robotic-assisted lung resection. [2012]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Activity-Based Cost Analysis of Robotic Anatomic Lung Resection During Program Implementation. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Robot-assisted Lung Surgery: Techniques, Evidence and Data on Anatomical Resections]. [2023]

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

Robotic-assisted lung resection for malignant disease. [2022]

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

Effects of da Vinci robot versus thoracoscopic surgery on body trauma and lymphocyte subsets in lung cancer patients: A propensity score matching study. [2023]

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. China pubmed.ncbi.nlm.nih.gov

Robotic lung resection: a narrative review of the current role on primary lung cancer treatment. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Is the Evaluation of Robot-Assisted Surgery Based on Sufficient Scientific Evidence? [2023]