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

NCT ID: NCT02948907

Last Updated: 2022-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-03-31

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.

Conditions

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Lymphadenopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Procedure/Bronchoscopy

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Indication for EBUS-TBNA
* Patient has provided written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Felix JF Herth

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felix Herth, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxklinik at University of Heidelberg

Locations

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Thoraxklinik

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 33027791 (View on PubMed)

Other Identifiers

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Protocol F1.0 - 22/05/2013

Identifier Type: -

Identifier Source: org_study_id

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