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

NCT ID: NCT01597869

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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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

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Conditions

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Ultrasound Complication

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Endobronchial ultrasound

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kyung Jong Lee

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung Jong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kyung Jong Lee, MD

Role: CONTACT

+82-2-3410-0777

Facility Contacts

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Kyung Jong Lee, MD

Role: primary

+82-2-3410-0777

Other Identifiers

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2012-02-009

Identifier Type: -

Identifier Source: org_study_id

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