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

This study is currently recruiting participants.
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
  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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kyung Jong Lee, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01597869     History of Changes
Other Study ID Numbers: 2012-02-009
Study First Received: May 10, 2012
Last Updated: January 1, 2013
Health Authority: South Korea: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014