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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
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mediastinal Lymphadenopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    March 13, 2015
    Last Updated
    March 20, 2015
    Sponsor
    Hannover Medical School
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    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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