NCT01597869

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Last Updated

January 3, 2013

Status Verified

January 1, 2013

Enrollment Period

9 months

First QC Date

May 10, 2012

Last Update Submit

January 1, 2013

Conditions

UltrasoundComplication

Outcome Measures

Primary Outcomes (1)

  • Complications related with EBUS-TBNA

    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

    1 month interval

Secondary Outcomes (1)

  • Risk factors related with the development of complications

    1 month interval

Interventions

Endobronchial ultrasoundDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admmitted to the tertiary hospital

You may qualify if:

  • Mediastinal lymph node enlargement on chest CT or PET-CT

You may not qualify if:

  • Inadequate oxygenation during procedure
  • uncontrolled cardiac arrythmia
  • Bleeding diathesis
  • Severe thrombocytopenia
  • Recent use of clopidogrel
  • Uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Study Officials

  • Kyung Jong Lee, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Jong Lee, MD

CONTACT

+82-2-3410-0777kj2011.lee@samsung.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2013

Last Updated

January 3, 2013

Record last verified: 2013-01

Locations

KR(1)