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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Kyung Jong Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597869
First Posted: May 14, 2012
Last Update Posted: January 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyung Jong Lee, Samsung Medical Center
  Purpose
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 Intervention
Ultrasound Complication Device: Endobronchial ultrasound

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

Resource links provided by NLM:


Further study details as provided by Kyung Jong Lee, Samsung Medical Center:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 300
Study Start Date: April 2012
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endobronchial ultrasound
    EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Kyung Jong Lee, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01597869     History of Changes
Other Study ID Numbers: 2012-02-009
First Submitted: May 10, 2012
First Posted: May 14, 2012
Last Update Posted: January 3, 2013
Last Verified: January 2013