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Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398864
Acronym
EBUS-nonM
Enrollment
120
Registered
2015-03-26
Start date
2015-03-31
Completion date
2017-06-30
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal Lymphadenopathy

Brief summary

To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

Detailed description

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging. Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy. It provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

Interventions

PROCEDUREEBUS with TBNA

endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults (18 Years and older) with mediastinal lymphadenopathy.

Exclusion criteria

* known or suspected malignancy * no informed consent * pts with anterior mediastinal lesions * contraindications to EBUS

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of EBUS-diagnosis2 yearsSensitivity defined as the proportion of participants with a positive EBUS-diagnosis accordant to final diagnosis, specificity, positive predictive value, negative predictive value and accuracy will be determined

Secondary

MeasureTime frameDescription
Risk factors related with the development of complications2 years1. Complications during procedure as Bleeding, pneumothorax, shock cardiac arrhythmia, change of oxygen desaturation 2. Complication after procedure as fever, mediastinitis, bleeding, pneumothorax and other complications after 24hr
Risk factors related with the procedure2 years1. dosage of sedative drugs 2. Procedure time 3. Total aspiration number 4. Location of sampled lymph node 5. Sampling number of lymph nodes 6. the development of comorbidities 7. Pulmonary function tests

Contacts

Primary ContactThomas Fuehner, MD
fuehner.thomas@mh-hannover.de+49 511 532
Backup ContactJens Gottlieb, MD
gottlieb.jens@mh-hannover.de+49 511 532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026