Image Guided VATS vs. VATS Resection

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective phase II clinical study to evaluate iVATS and standard VATS for small pulmonary nodules. We have successfully completed and published a phase I/pilot study with 25 patients demonstrating safety and optimal procedural workflow for combining image-guidance with VATS. This phase II clinical study will further expand upon the safety and feasibility of this procedure. Additionally, this data will be used to design a phase III comparison study between iVATS and standard VATS.

Official Title
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Image Guided VATS Resection vs. VATS Resection of Lung Lesions

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection
* Procedure: Video-Assisted Thoracic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be 18 years and older Subject must be deemed a candidate for the iVATS surgery, by their treating Thoracic Surgeon Subject must have nodules/GGO or other abnormal opacity that can be accurately measured in at least one dimension with longest diameter ≤ 20 mm or 2cm Subject's lesions that are located in the outer half portion of the lung/lobe. Subjects must be evaluated at BWH and/or DFCI Thoracic Surgery outpatient clinics 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iVATS resection<br>Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy. | Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection<br>* Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed<br>|
| Active Comparator: Standard VATS resection<br>Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room. | Procedure: Video-Assisted Thoracic Surgery<br>* Standard of Care Video-Assisted Thoracic Surgery (VATS) resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operating Room Time | The time (in min.) from incision to close | 3 years to complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to T-bar placement | The time from patient ready for surgery to placement of t-bar | 3 years | 
| Time for induction to incision | Time (in min) from induction to incision made | 3 years | 
| Hospital Length of Stay | Length of hospital stay (in days) in both arms | 3 years | 
| Radiation Exposure | The radiation exposure (mSV) in the iVATS arm | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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image guided, lung nodule, lung cancer, lung mass