Image Guided VATS vs. VATS Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Image guided Video-Assisted Thoracic Surgery (VATS) resection, Video-Assisted Thoracic Surgery.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Image Guided VATS Resection vs. VATS Resection of Lung Lesions
Overview
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.
Interventions
- Device Image guided Video-Assisted Thoracic Surgery (VATS) resection
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 - Procedure Video-Assisted Thoracic Surgery
Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
Primary outcome measures
- Operating Room Time [Time frame: 3 years to complete]
Secondary outcome measures (4)
- Time to T-bar placement [Time frame: 3 years]
- Time for induction to incision [Time frame: 3 years]
- Hospital Length of Stay [Time frame: 3 years]
- Radiation Exposure [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Publications
- Gill RR, Zheng Y, Barlow JS, Jayender J, Girard EE, Hartigan PM, Chirieac LR, Belle-King CJ, Murray K, Sears C, Wee JO, Jaklitsch MT, Colson YL, Bueno R. Image-guided video assisted thoracoscopic surgery (iVATS) - phase I-II clinical trial. J Surg Oncol. 2015 Jul;112(1):18-25. doi: 10.1002/jso.23941. Epub 2015 May 28. PMID 26031893
Identifiers
NCT: NCT03623958 · 2017P000291