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

• Conditions: Ultrasound; Complication

• Registration Number: NCT01597869
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Last Update Submitted: 2013-01-01
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications related with EBUS-TBNA	1 month interval	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

Name	Time	Method
Risk factors related with the development of complications	1 month interval	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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of