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Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

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ClinicalTrials.gov Identifier: NCT01597869
Recruitment Status : Unknown
Verified January 2013 by Kyung Jong Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 14, 2012
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
Kyung Jong Lee, Samsung Medical Center

Brief Summary:
The purpose of this study is to find all kinds of complications and it's frequency related to the Endobronchial Ultrasound- Transbronchial Needle Aspiration (EBUS-TBNA) and to evaluate associated risk factors in patients who developed complications. The investigators performs EBUS-TBNA examination on all subjects that need mediastinal evaluation. All complications during or after the procedure will be recorded prospectively.

Condition or disease Intervention/treatment
Ultrasound Complication Device: Endobronchial ultrasound

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
Study Start Date : April 2012
Estimated Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources


Intervention Details:
    Device: Endobronchial ultrasound
    EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.


Primary Outcome Measures :
  1. Complications related with EBUS-TBNA [ Time Frame: 1 month interval ]
    1. Complications during procedure

      • Bleeding
      • pneumothorax
      • shock
      • cardiac arrythmia
      • change of oxygen saturation
    2. Complication after procedure

      • fever
      • bleeding
      • pneumothorax
      • all other comlications after 24hr


Secondary Outcome Measures :
  1. Risk factors related with the development of complications [ Time Frame: 1 month interval ]
    1. Midazolam/Lidocaine dosage
    2. Procedure time
    3. Total aspiration number
    4. Location of sampled lymph node
    5. Sampling number of lymph nodes
    6. Underlying disease
    7. Pulmonary function test



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admmitted to the tertiary hospital
Criteria

Inclusion Criteria:

  • Mediastinal lymph node enlargement on chest CT or PET-CT

Exclusion Criteria:

  • Inadequate oxygenation during procedure
  • uncontrolled cardiac arrythmia
  • Bleeding diathesis
  • Severe thrombocytopenia
  • Recent use of clopidogrel
  • Uncooperative patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597869


Contacts
Contact: Kyung Jong Lee, MD +82-2-3410-0777 kj2011.lee@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyung Jong Lee, MD    +82-2-3410-0777    kj2011.lee@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyung Jong Lee, MD Samsung Medical Center

Responsible Party: Kyung Jong Lee, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01597869     History of Changes
Other Study ID Numbers: 2012-02-009
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013