Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound
| Status: | Terminated |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/9/2018 |
| Start Date: | July 1, 2015 |
| End Date: | June 27, 2018 |
A Single-arm, Phase II Study of Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound at the Time of Definitive Resection
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.
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.
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)
We found this trial at
1
site
Lexington, Kentucky
Principal Investigator: Angela Mahan, MD
Click here to add this to my saved trials
