Skip to main content
OpenTrials
Completed

NCT Number: NCT02948907

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphadenopathy Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thoraxklinik

Heidelberg, D-69126, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"

    Time frame: Once after bronchoscopic procedure

    Correlation of imaging results and cytological results after bronchoscopic procedure

Secondary outcomes

  1. Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events

    Time frame: during diagnostic bronchoscopy procedure

    Incidence of adverse events (e.g. bleeding, pneumothorax)

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Oct 31, 2016
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.