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
  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
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, see Learn About Clinical Studies.

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 August 28, 2014