Back to results"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Primary Purpose
Lymphadenopathy
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Procedure/Bronchoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphadenopathy
Eligibility Criteria
Inclusion Criteria:
- Indication for EBUS-TBNA
- Patient has provided written informed consent
Sites / Locations
- Thoraxklinik
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Procedure/Bronchoscopy
Arm Description
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.
Outcomes
Primary Outcome Measures
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
Correlation of imaging results and cytological results after bronchoscopic procedure
Secondary Outcome Measures
Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events
Incidence of adverse events (e.g. bleeding, pneumothorax)
Full Information
NCT ID
NCT02948907
First Posted
September 19, 2016
Last Updated
August 30, 2022
Sponsor
Heidelberg University
1. Study Identification
Unique Protocol Identification Number
NCT02948907
Brief Title
"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Official Title
Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphadenopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Procedure/Bronchoscopy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Procedure/Bronchoscopy
Intervention Description
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 Outcome Measure Information:
Title
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
Description
Correlation of imaging results and cytological results after bronchoscopic procedure
Time Frame
Once after bronchoscopic procedure
Secondary Outcome Measure Information:
Title
Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events
Description
Incidence of adverse events (e.g. bleeding, pneumothorax)
Time Frame
during diagnostic bronchoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication for EBUS-TBNA
Patient has provided written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix Herth, MD
Organizational Affiliation
Thoraxklinik at University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33027791
Citation
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.
Results Reference
result
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"Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
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