Image Guided VATS vs. VATS Resection

Mass General Brigham

Status: Enrolling

Conditions: Lung Cancer

Treatments: Procedure: Video-Assisted Thoracic Surgery; Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03623958

2017P000291

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

iVATS resection

Experimental group

Description:

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

Treatment:

Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection

Standard VATS resection

Active Comparator group

Description:

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

Treatment:

Procedure: Video-Assisted Thoracic Surgery