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

Sponsor

Hannover Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT02398864

Collaborator

(none)

120

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mediastinal Lymphadenopathy	Procedure: EBUS with TBNA	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endobronchial ultrasound bronchoscopy EBUS with TBNA	Procedure: EBUS with TBNA endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)

Arm

Intervention/Treatment

Experimental: endobronchial ultrasound bronchoscopy

EBUS with TBNA

Procedure: EBUS with TBNA

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

Outcome Measures

Primary Outcome Measures

Sensitivity of EBUS-diagnosis [2 years]
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

Secondary Outcome Measures

Risk factors related with the development of complications [2 years]
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
Risk factors related with the procedure [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hannover Medical School

Investigators

Principal Investigator: Thomas Fuehner, MD, Hannover Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hannover Medical School

ClinicalTrials.gov Identifier:

NCT02398864

Other Study ID Numbers:

1203-2015

First Posted:

Mar 26, 2015

Last Update Posted:

Mar 26, 2015

Last Verified:

Mar 1, 2015

Additional relevant MeSH terms:

Lymphadenopathy

Study Results

No Results Posted as of Mar 26, 2015