Lymphadenopathy
Conditions
Brief summary
Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and Tissue Harmonic Imaging (THI) might be useful for the differentiation of benign and malignant lymph nodes.
Detailed description
Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.
Interventions
OTHERProcedure/Bronchoscopy
Patients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes endobronchial ultrasound with elastography and Tissue Harmonic Imaging (THI) are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological result obtained by EBUS-TBNA.
Sponsors
Heidelberg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indication for EBUS-TBNA * Patient has provided written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of elastography and Tissue Harmonic Imaging | Once after bronchoscopic procedure | Correlation of imaging results and cytological results after bronchoscopic procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of endobronchial use of elastography and Tissue Harmonic Imaging assessed by Incidence of adverse events | during diagnostic bronchoscopy procedure | Incidence of adverse events (e.g. bleeding, pneumothorax) |
Countries
Germany
Outcome results
None listed