Image-Guided VATS vs. Standard VATS for Lung Cancer

Overseen By Julianne S Barlow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pregnancy, Breastfeeding, Surgeon ineligibility

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

200 Participants Needed

Trial Summary

What is the purpose of this trial?

To evaluate workflow and outcomes of iVATS and standard VATS for small pulmonary nodules. The outcomes of the patients will be evaluated separately as there will be no direct comparison of the two arms.

Research Team

Raphael Bueno, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with small lung nodules or opacities no larger than 20 mm, suitable for iVATS surgery, and whose lesions are in the outer half of the lung. Candidates must be evaluated at specific thoracic surgery clinics. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

I have a lung spot or shadow smaller than 2cm that can be measured.

My surgeon has approved me for iVATS surgery.

My cancer is in the outer part of my lung.

Exclusion Criteria

If participant is a pregnant woman or breast feeding they will not be eligible

If treating thoracic surgeon deems the participant not eligible for the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either standard VATS or iVATS resection for small pulmonary nodules

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hospital length of stay and radiation exposure

3 years

Treatment Details

Interventions

• Image Guided Video-Assisted Thoracic Surgery (VATS) resection
• Video-Assisted Thoracic Surgery

Trial Overview The study is examining two surgical methods for removing small pulmonary nodules: image-guided Video-Assisted Thoracic Surgery (iVATS) versus standard VATS. Each patient's outcomes will be assessed individually without direct comparison between the two groups.

Participant Groups

Group I: iVATS resection Experimental Treatment 1 Intervention

Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.

Group II: Standard VATS resection Active Control 1 Intervention

Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+