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

Not Applicable

• Conditions: Mediastinal Lymphadenopathy
• Interventions: Procedure: EBUS with TBNA

• Registration Number: NCT02398864
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-20
• Last Update Submitted: 2015-03-20
• Study First Posted: 2015-03-26
• Last Update Posted: 2015-03-26
• Primary Completion: 2017-03
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endobronchial ultrasound bronchoscopy	EBUS with TBNA	EBUS with TBNA

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Risk factors related with the procedure	2 years	1. 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
Risk factors related with the development of complications	2 years	1. 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