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

Not Applicable

Completed

• Conditions: Lymphadenopathy
• Interventions: Other: Procedure/Bronchoscopy

• Registration Number: NCT02948907
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-09-19
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-10-31
• Primary Completion: 2019-12-01
• Study Completion: 2020-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Indication for EBUS-TBNA
• Patient has provided written informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Procedure/Bronchoscopy	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 results obtained by EBUS-TBNA.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"	Once after bronchoscopic procedure	Correlation of imaging results and cytological results after bronchoscopic procedure

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Thoraxklinik; 🇩🇪 Heidelberg, Germany