Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy (EBUS-nonM)
Primary Purpose
Mediastinal Lymphadenopathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EBUS with TBNA
Sponsored by
About this trial
This is an interventional diagnostic trial for Mediastinal Lymphadenopathy
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endobronchial ultrasound bronchoscopy
Arm Description
EBUS with TBNA
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02398864
Brief Title
Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy
Acronym
EBUS-nonM
Official Title
Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mediastinal Lymphadenopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
endobronchial ultrasound bronchoscopy
Arm Type
Experimental
Arm Description
EBUS with TBNA
Intervention Type
Procedure
Intervention Name(s)
EBUS with TBNA
Intervention Description
endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)
Primary Outcome Measure Information:
Title
Sensitivity of EBUS-diagnosis
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Risk factors related with the development of complications
Description
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
Time Frame
2 years
Title
Risk factors related with the procedure
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Fuehner, MD
Phone
+49 511 532
Ext
2699
Email
fuehner.thomas@mh-hannover.de
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Gottlieb, MD
Phone
+49 511 532
Ext
4681
Email
gottlieb.jens@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Fuehner, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy
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