Elastography and Tissue Harmonic Imaging for Characterisation of Hilar and Mediastinal Lymph Nodes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endobronchial Ultrasound Elastography and Tissue Harmonic Imaging for Characterisation of Hilar and Mediastinal Lymph Nodes

Conditions
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Lymphadenopathy

Intervention / Treatment
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* Other: Procedure/Bronchoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for EBUS-TBNA Patient has provided written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Procedure/Bronchoscopy<br>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 results obtained by EBUS-TBNA. | Other: Procedure/Bronchoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of elastography and Tissue Harmonic Imaging | Correlation of imaging results and cytological results after bronchoscopic procedure | Once after bronchoscopic procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of endobronchial use of elastography and Tissue Harmonic Imaging assessed by Incidence of adverse events | Incidence of adverse events (e.g. bleeding, pneumothorax) | during diagnostic bronchoscopy procedure |