Comparing robotic and video-assisted surgery for early-stage lung cancer
Comparing Outcomes for Minimally Invasive Techniques for Anatomic Lung Resection for Cancer - A Prospective, Comparative, Non-randomized, Open Label Post-market Observational Cohort Study Within Europe
This study is testing whether robotic surgery or video-assisted surgery is better for people with early-stage lung cancer to see how they recover and feel afterwards.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 512 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Intuitive Surgical Industry-sponsored |
| Locations | 12 sites (Copenhagen and 11 other locations) |
| Trial ID | NCT06038227 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of minimally invasive surgical techniques, specifically robotic-assisted thoracic surgery (RATS) and video-assisted thoracic surgery (VATS), for treating early-stage non-small cell lung cancer (NSCLC). It focuses on patients diagnosed with clinical stage IA1-2 lung cancer who are scheduled for these surgical procedures. The study will evaluate perioperative outcomes and the real-world selection process for these techniques, while also assessing health-related quality of life to provide insights into recovery times and disease burden.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with clinical stage IA1-2 non-small cell lung cancer scheduled for minimally invasive surgery.
Not a fit: Patients with more advanced stages of lung cancer or those requiring emergency surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical options and outcomes for patients with early-stage lung cancer.
How similar studies have performed: Previous studies have shown promising results for robotic-assisted surgeries in lung cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure * Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs * Aged ≥ 18 years * Must be willing and able to comply with study requirements * Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form Exclusion Criteria: * Patients with clinical stage IA3, II, III, and IV lung cancer * Patient receiving a lobectomy/segmentectomy as an emergency procedure * Patients receiving a lobectomy/segmentectomy for metastatic cancer * Patients scheduled to receive a bilobectomy or sleeve-lobectomy * Mental incapacity to understand or consent to study procedures * Anticipated difficulty for patient to comply with protocol requirements * Unable to comply with the follow up schedule * Pregnant or are planning to become pregnant during the study * Life expectancy \< 12 months
Where this trial is running
Copenhagen and 11 other locations
- Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Ap-Hm — Marseille, France (Recruiting)
- CHU de Rouen — Rouen, France (Recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
- Thoraxklinik — Heidelberg, Germany (Recruiting)
- Krankenhaus Barmherzige Brüder — Regensburg, Germany (Recruiting)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
- Akershus University Hospital — Loerenskog, Norway (Recruiting)
- University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom (Recruiting)
- University Hospitals Coventry and Warwickshire NHS Trust — Coventry, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- St Bartholomew Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tom Routledge — Guy's St Thomas' NHS Foundation Trust, UK
- Study coordinator: Marie Allouis
- Email: Marie.Allouis@intusurg.com
- Phone: +33786480495
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.