Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

This is a prospective randomized clinical trial of males and females age 21 or older being
evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each
arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample
size will provide sufficient statistical power (i.e. >80%) using a non-inferiority study
design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or
not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more
lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%.
This study requires subjects to agree to the selection of their standard of care procedure.
Subjects will be randomized (stratified computer generated randomization stratified y center
and y CT positivity for pathologically enlarged [>1cm short axis] node - 10 strata).
Randomization will use variable block sizes (4-8), so that randomization allocation remains
concealed as investigators will not be blinded. This study requires subjects to consent to
the release of outcome data and follow-up data to be used for study analysis. No additional
visit will be required for this study; this study will not require any additional time
requirements beyond their scheduled evaluations.