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

Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01597869
• Other study ID #: 2012-02-009
• 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. 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

• Complication
• Ultrasound

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