Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01597869
Enrollment
300
Registered
2012-05-14
Start date
2012-04-30
Completion date
Unknown
Last updated
2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultrasound, Complication

Brief 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.

Interventions

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

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Complications related with EBUS-TBNA1 month interval1. 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

MeasureTime frameDescription
Risk factors related with the development of complications1 month interval1. 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

Countries

South Korea

Contacts

Primary ContactKyung Jong Lee, MD
kj2011.lee@samsung.com+82-2-3410-0777

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026