Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

Not Applicable

Terminated

Conditions: Lung Cancer

Registration Number: NCT02218242

Lead Sponsor: Joel Thompson, PhD

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

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:

Preoperative Forced Expiratory Volume at one second ≥ 40% predicted
OR
Post-operative predicted Forced Expiratory Volume at one second ≥ 0.8 l
Hg ≥ 8.0
No evidence of coronary ischemia on stress evaluation Ability to understand and the willingness to sign a written informed consent document.

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection of Occult Pathologic N2 Lymph Nodes	At time of surgery	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): University of Kentucky, Markey Cancer Center
🇺🇸
Lexington, Kentucky, United States
University of Kentucky, Markey Cancer Center
🇺🇸Lexington, Kentucky, United States