Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

NCT ID: NCT02218242

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-01
• Study Completion Date: 2018-06-27

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound

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.

Group Type: EXPERIMENTAL

Intraoperative ultrasound

Intervention Type: 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.

Interventions

Intraoperative ultrasound

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.

Intervention Type: DEVICE

Other Intervention Names

B-K Medical/Analogic 8666-Radio Frequency laparoscopic ultrasound transducer and the bedside flex Focus 1202 imaging system

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joel Thompson, PhD

OTHER

Sponsor Role: lead

Responsible Party

Joel Thompson, PhD

Compliance Administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joel Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-LUN-95-MCC

Identifier Type: -

Identifier Source: org_study_id