NCT02948907

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

4.3 years

First QC Date

September 19, 2016

Last Update Submit

August 30, 2022

Conditions

Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"

    Correlation of imaging results and cytological results after bronchoscopic procedure

    Once after bronchoscopic procedure

Secondary Outcomes (1)

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

    during diagnostic bronchoscopy procedure

Study Arms (1)

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 results obtained by EBUS-TBNA.

Other: Procedure/Bronchoscopy

Interventions

Procedure/BronchoscopyOTHER

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.

Procedure/Bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thoraxklinik

Heidelberg, D-69126, Germany

Location

Related 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.

    PMID: 33027791RESULT

MeSH Terms

Conditions

Lymphadenopathy

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Felix Herth, MD

    Thoraxklinik at University of Heidelberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 19, 2016

First Posted

October 31, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

September 2, 2022

Record last verified: 2022-08

Locations

DE(1)