UltrasoundNCT01597869
Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
An observational study of Ultrasound and Complication, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Complication
- What is being tested?
- Endobronchial ultrasound
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admmitted to the tertiary hospital
Who may be able to join
- Mediastinal lymph node enlargement on chest CT or PET-CT
Who cannot join
- Inadequate oxygenation during procedure
- uncontrolled cardiac arrythmia
- Bleeding diathesis
- Severe thrombocytopenia
- Recent use of clopidogrel
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Kyung Jong Lee, MD, +82-2-3410-0777, kj2011.lee@samsung.com
About this study
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.
- Conditions
- Ultrasound, Complication
- Being tested
- Endobronchial ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasoundDevice
EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month interval
Secondary outcomes (1)
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
Measured: 1 month interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Jong Lee, Samsung Medical Center
- Investigators
- Kyung Jong Lee, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597869
- Sponsor's protocol ID
- 2012-02-009
- Status last verified
- Jan 2013
- First submitted
- 10 May 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration : A Prospective Study
- ClinicalTrials.gov ID
- NCT01597869
- Acronym / sponsor ID
- 2012-02-009
- Conditions
- Ultrasound, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (estimated)
- First posted
- 14 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admmitted to the tertiary hospital
Key inclusion criteria (1 listed)
- Mediastinal lymph node enlargement on chest CT or PET-CT
Key exclusion criteria (6 listed)
- Inadequate oxygenation during procedure
- uncontrolled cardiac arrythmia
- Bleeding diathesis
- Severe thrombocytopenia
- Recent use of clopidogrel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial ultrasoundEBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions. | Device | – |
Primary outcome
Complications related with EBUS-TBNA
Time frame: 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
1 secondary outcome
Risk factors related with the development of complications
Time frame: 1 month interval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Jong Lee, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Complication, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Jong Lee, MD (+82-2-3410-0777, kj2011.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications related with EBUS-TBNA (time frame: 1 month interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.