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Thoracoscopic Lung Cancer Staging With the Use of Intraoperative Ultrasound

NCT02218242 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-11-07

Study results available
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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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Joel Thompson, PhD

    lead OTHER

Principal Investigators

  • Joel Thompson, PhD · University of Kentucky

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2018-06-27
Completion
2018-06-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218242 on ClinicalTrials.gov