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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01597869
Other study ID # 2012-02-009
Secondary ID
Status Recruiting
Phase N/A
First received May 10, 2012
Last updated January 1, 2013
Start date April 2012

Study information

Verified date January 2013
Source Samsung Medical Center
Contact Kyung Jong Lee, MD
Phone +82-2-3410-0777
Email kj2011.lee@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complications related with EBUS-TBNA Complications during procedure
Bleeding
pneumothorax
shock
cardiac arrythmia
change of oxygen saturation
Complication after procedure
fever
bleeding
pneumothorax
all other comlications after 24hr
1 month interval No
Secondary Risk factors related with the development of complications Midazolam/Lidocaine dosage
Procedure time
Total aspiration number
Location of sampled lymph node
Sampling number of lymph nodes
Underlying disease
Pulmonary function test
1 month interval No
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