Study Results
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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COMPLETED
NA
250 participants
INTERVENTIONAL
2016-05-31
2017-12-14
Brief Summary
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This study aims to establish whether the use of the Flex 19G EBUS-TBNA needle can improve the diagnostic yield of EBUS sampling procedures compared to the use of the conventional TBNA needle, thereby allowing more accurate diagnoses and reducing the need repeat procedures or more invasive surgical biopsies, without causing an increase in complication rates. Patients with enlarged mediastinal and hilar lymph nodes referred for EBUS-TBNA will be randomised to have their nodes sampled by either the EBUS-TBNA needle (conventional procedure) or the novel Flex 19G EBUS-TBNA needle. The investigators hope to recruit 250 patients over a 24 month period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Flex 19G EBUS-TBNA
Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle
Flexible 19G EBUS-TBNA needle
EBUS-TBNA
Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle
21G EBUS-TBNA needle
Interventions
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Flexible 19G EBUS-TBNA needle
21G EBUS-TBNA needle
Eligibility Criteria
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Inclusion Criteria
* Lymph nodes larger than 10mm in diameter
* Age \> 18 years
* Written informed consent
Exclusion Criteria
* Inability to obtain informed consent
18 Years
ALL
No
Sponsors
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Olympus Corporation
INDUSTRY
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Pallav L Shah, MBBS MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton and Harefield NHS Foundation Trust
Locations
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Royal Brompton Hospital
London, , United Kingdom
Countries
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Other Identifiers
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2015LF016B
Identifier Type: -
Identifier Source: org_study_id
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