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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iVATS resection | Experimental | 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 | Active Comparator | Standard video-assisted thoracoscopic surgery (VATS) in operating room and Fine Needle Aspiration (FNA) in pathology frozen section room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image guided Video-Assisted Thoracic Surgery (VATS) resection | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operating Room Time | The time (in min.) from incision to close | 3 years to complete |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative Analysis of CT scans | To collect imaging data from pre-operative and post-operative CT scans for quantitative analysis from both arm. | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julianne S Barlow | Contact | 617-525-8704 | jbarlow1@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Raphael Bueno, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26031893 | Result | 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. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D013906 | Thoracoscopy |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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| Video-Assisted Thoracic Surgery | Procedure | Standard of Care Video-Assisted Thoracic Surgery (VATS) resection |
|
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |