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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Kyung Jong Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01597869
First received: May 10, 2012
Last updated: January 1, 2013
Last verified: January 2013

May 10, 2012
January 1, 2013
April 2012
January 2013   (final data collection date for primary outcome measure)
Complications related with EBUS-TBNA [ Time Frame: 1 month interval ] [ Designated as safety issue: No ]
  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
Same as current
Complete list of historical versions of study NCT01597869 on ClinicalTrials.gov Archive Site
Risk factors related with the development of complications [ Time Frame: 1 month interval ] [ Designated as safety issue: No ]
  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
Same as current
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Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients admmitted to the tertiary hospital

  • Ultrasound
  • Complication
Device: Endobronchial ultrasound
EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Not Provided
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kyung Jong Lee, MD +82-2-3410-0777 kj2011.lee@samsung.com
Korea, Republic of
 
NCT01597869
2012-02-009
Yes
Kyung Jong Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Kyung Jong Lee, MD Samsung Medical Center
Samsung Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP