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All patients undergoing video-assisted thoracoscopic (VATS) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. After completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. Data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. It is hypothesized that Intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (VATS) dissection will increase the rate of pathologically staged in N2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound | Experimental | Participants in this study have elected to have surgical resection of non-small cell lung cancer tumors as part of their standard of care. During that surgical procedure, participants will also receive laparoscopic intraoperative ultrasound to assess the thoracic wall lymph nodes as part of the experimental procedure. The ultrasound procedure will add about 15 minutes to the total surgical time. Because it is laparoscopic and utilizes non-ionizing radiation, the risk to the participant is minimal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative ultrasound | Device | Intraoperative ultrasound will be performed at the completion of the standard lung cancer resection with mediastinal lymph node dissection. This evaluation will be performed by a different surgeon from the primary surgeon performing the operation to minimize operator variability with the ultrasound system and help control for bias. Additional lymph nodes identified will be resected and sent for pathologic evaluation. It is anticipated that this additional evaluation and treatment should take no more than 30 minutes and as such a time limit of 30 minutes from introduction of the ultrasound probe into the surgical field will be set. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of Occult Pathologic N2 Lymph Nodes | Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique. | At time of surgery |
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Inclusion Criteria:
Age ≥18 years. Eastern Cooperative Oncology Group performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Life expectancy of greater than 3 months
Patients be able to undergo VATS resection as defined below:
Exclusion Criteria:
Patients with surgery for a prior ipsilateral lung cancer
Patients with known brain metastases
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (Patients with HIV are not excluded from this study)
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| Name | Affiliation | Role |
|---|---|---|
| Joel Thompson, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky, Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound | Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound | Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age information was collected at the time of consenting |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Detection of Occult Pathologic N2 Lymph Nodes | Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique. | An insufficient number of participants were consented to generate meaningful data for this study. We reached an enrollment of less than 10% of what our power calculations suggested we needed. No pathologic lymph nodes were identified, thus the percent of pathologic lymph nodes is in fact zero | Posted | Number | percentage of pathologic lymph nodes | At time of surgery | lymph nodes | lymph nodes |
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Adverse events were collected in the operating room at the time of the procedure. Typically less that 30 minutes.
Patients were assessed for adverse events through investigator assessment at the time of the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound | Intraoperative ultrasound Intraoperative ultrasound: Intraoperative ultrasound |
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The University of Kentucky Medical Center did not treat a sufficient patient population to enroll and complete this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Mahan | University of Kentucky | 859 257 4488 | angela.mahan@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2013 | Jun 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
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|
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| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D012140 |
| Respiratory Tract Diseases |