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

Mediastinal Lymphadenopathy Clinical Trial

— EBUS-nonM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02398864
• Other study ID #: 1203-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: March 20, 2015
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2015
• Source: Hannover Medical School
• Contact: Thomas Fuehner, MD
• Phone: +49 511 532
• Email: fuehner.thomas[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Mediastinal Lymphadenopathy

Intervention

Procedure:
• EBUS with TBNA
endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of EBUS-diagnosis	Sensitivity 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	2 years	Yes
Secondary	Risk factors related with the development of complications	Complications during procedure as Bleeding, pneumothorax, shock cardiac arrhythmia, change of oxygen desaturation; Complication after procedure as fever, mediastinitis, bleeding, pneumothorax and other complications after 24hr	2 years	Yes
Secondary	Risk factors related with the procedure	dosage of sedative drugs; Procedure time; Total aspiration number; Location of sampled lymph node; Sampling number of lymph nodes; the development of comorbidities; Pulmonary function tests	2 years	Yes