Image Guided VATS vs. VATS Resection

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Device: Image guided Video-Assisted Thoracic Surgery (VATS) resection; Procedure: Video-Assisted Thoracic Surgery

• Registration Number: NCT03623958
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-07-20
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-09
• Study Start: 2018-09-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iVATS resection	Image guided Video-Assisted Thoracic Surgery (VATS) resection	Image guided Video-assisted thoracoscopic surgery (VATS) in either one of two hybrid operating rooms and Fine Needle Aspiration (FNA) under fluoroscopy.
Standard VATS resection	Video-Assisted Thoracic Surgery	Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room.

Primary Outcome Measures

Name	Time	Method
Operating Room Time	3 years to complete	The time (in min.) from incision to close

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States