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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure/Bronchoscopy | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Bronchoscopy | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felix Herth, MD | Thoraxklinik at University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thoraxklinik | Heidelberg | D-69126 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33027791 | Result | Gompelmann D, Kontogianni K, Sarmand N, Kaukel P, Krisam J, Eberhardt R, Herth FJF. Endobronchial Ultrasound Elastography for Differentiating Benign and Malignant Lymph Nodes. Respiration. 2020;99(9):779-783. doi: 10.1159/000509297. Epub 2020 Oct 7. |
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| ID | Term |
|---|---|
| D000072281 | Lymphadenopathy |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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|
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |