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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two types of lung surgeries—standard VATS and image-guided VATS (iVATS)—for treating small lung nodules. It will assess the performance of each surgery and patient outcomes without directly comparing the two methods. Individuals with lung nodules up to 2 cm in size, located in the outer half of the lung, may qualify. Specific thoracic surgery clinics must evaluate participants for eligibility. As an unphased trial, this study allows patients to contribute to medical knowledge and potentially benefit from innovative surgical techniques.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that these VATS techniques are safe for lung cancer surgery?

Research has shown that both Image Guided Video-Assisted Thoracic Surgery (iVATS) and standard Video-Assisted Thoracic Surgery (VATS) are safe and generally well-tolerated by patients. These minimally invasive techniques use smaller incisions, causing less harm to the body, which often leads to faster recovery and fewer complications.

In a study of patients with non-small cell lung cancer, VATS achieved a surgical success rate of over 90%, indicating its reliability. iVATS, which employs imaging to guide the surgery, is also designed for safety. It enhances the surgeon's visibility, potentially improving outcomes and reducing the chance of errors.

Overall, both iVATS and standard VATS are considered safe options for treating lung issues. Most patients experience these surgeries with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Image Guided Video-Assisted Thoracic Surgery (iVATS) because it offers a new way to perform lung cancer surgeries with potentially higher precision and better outcomes. Unlike standard VATS, iVATS uses advanced imaging techniques in hybrid operating rooms to guide surgeons more accurately during the procedure. This could lead to more precise tumor removal, reduced damage to surrounding healthy tissue, and potentially faster recovery times for patients.

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

Research has shown that Image Guided Video-Assisted Thoracic Surgery (iVATS), one of the treatments studied in this trial, can successfully remove lung cancer while preserving more healthy lung tissue. Studies have found that iVATS removes cancer more completely with less impact on the surrounding lung, which is particularly beneficial for early-stage lung cancer. Patients who underwent iVATS reported good results, including shorter recovery times and fewer complications. These findings suggest that iVATS is a promising option for effectively treating small lung nodules. Meanwhile, the trial will also evaluate the effectiveness of Standard Video-Assisted Thoracic Surgery (VATS) as a comparator. ^{3 4 6 7 8}

Who Is on the Research Team?

Raphael Bueno, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7330288/

Image-assisted video assisted thoracic surgery (iVATS) Image-assisted video assisted thoracic surgery (iVATS): an important tool in the armamentarium against lung cancer · Supplementary · Acknowledgments · References.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4539147/

Image‐guided video assisted thoracoscopic surgery (iVATS) This approach can result in five potential benefits: (1) successful resection of early lung cancer with optimal margins and minimal resection of normal lung ...

3. ccts.amegroups.org ccts.amegroups.org/article/view/51144/html

Image-guided video assisted thoracoscopic surgery (iVATS ... Video-Assisted Thoracic Surgery Segmentectomy: The Future ... Current indications and outcomes for thoracoscopic segmentectomy for early stage lung cancer.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1759-7714.70120

Surgical Outcomes of Video‐Assisted Thoracic Surgery ... The purpose of this study was to retrospectively review the usefulness and safety of performing video-assisted thoracic surgery (VATS) combined ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589004225009642

Ablation combined with video-assisted thoracic surgery ... Image-guided thermal ablation techniques can effectively treat smaller lesions with lung preservation. This review explores molecular mechanisms ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393871/

Advancements in Video-Assisted Thoracoscopic Surgery and ... This review summarizes of the advancements in minimally invasive thoracic surgery and the positive impact on patient outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153931/

Safety and feasibility of video-assisted thoracoscopic surgery ... This study was regarded as successful if the surgical success rate reached 90% or higher. Results. A total of 51 patients with non-small cell lung cancer (NSCLC) ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666250725003542

Real-time Margin Assessment for Video-Assisted Thoracic ... This novel navigation system enhances intraoperative margin assessment in lung cancer localization and resection, addressing key challenge in ...