Skip to content

Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02009319
Enrollment
33
Registered
2013-12-12
Start date
2013-08-31
Completion date
2014-03-31
Last updated
2015-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

endobronchial ultrasound, EBUS - TBNA, elastography, strain ratio, lung cancer staging

Brief 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.

Interventions

None listed

Sponsors

The University Clinic of Pulmonary and Allergic Diseases Golnik
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
elastography strain ratioup to 7 monthsSensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026