Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
endobronchial ultrasound, EBUS - TBNA, elastography, strain ratio, lung cancer staging
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.
Detailed Description
Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- enlarged discrete N2/N3 lymph nodes

- central tumor with normal mediastinal lymph nodes

- enlarged N1 lymph nodes with normal mediastinal lymph nodes

Exclusion Criteria:

- metastatic disease

- severe co-morbidity that disqualified surgical treatment

- mediastinal infiltration by tumor

- small peripheral lung tumor with normal-sized mediastinal lymph nodes
Location
University Clinic of Pulmonary and Allergic Diseases Golnik
Golnik, Slovenia
Status: Recruiting
Contact: Ales Rozman, MD, specialist - +39641313811 - ales.rozman@klinika-golnik.si
Start Date
August 2013
Completion Date
March 2014
Sponsors
The University Clinic of Pulmonary and Allergic Diseases Golnik
Source
The University Clinic of Pulmonary and Allergic Diseases Golnik
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page