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

NCT ID: NCT02398864

Last Updated: 2015-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-06-30

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.

Conditions

Mediastinal Lymphadenopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

endobronchial ultrasound bronchoscopy

EBUS with TBNA

Group Type: EXPERIMENTAL

EBUS with TBNA

Intervention Type: PROCEDURE

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

Interventions

EBUS with TBNA

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Fuehner, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Central Contacts

Thomas Fuehner, MD

Role: CONTACT

fuehner.thomas@mh-hannover.de

+49 511 532 ext. 2699

Jens Gottlieb, MD

Role: CONTACT

gottlieb.jens@mh-hannover.de

+49 511 532 ext. 4681

Other Identifiers

1203-2015

Identifier Type: -

Identifier Source: org_study_id