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NCT02948907 Clinical Trial

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

Lymphadenopathy Clinical Trial

Official title:
Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02948907
Other study ID # Protocol F1.0 - 22/05/2013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date March 2020

Study information
Verified date August 2022
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Indication for EBUS-TBNA - Patient has provided written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Procedure/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.

Locations
Country Name City State
Germany Thoraxklinik Heidelberg

Sponsors (1)
Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of elastography and "Tissue Harmonic Imaging" Correlation of imaging results and cytological results after bronchoscopic procedure Once after bronchoscopic procedure
Secondary 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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