Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

Stopped early · Not applicable

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT02218242

Run by

Joel Thompson, PhD

People needed

9

Starts

2015-07-01

Expected to finish

2018-06-27

Last updated by the study team

2018-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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