Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.
NCT ID: NCT02739126
Last Updated: 2016-04-15
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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UNKNOWN
NA
88 participants
INTERVENTIONAL
2015-01-31
2017-12-31
Brief Summary
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There are 2 types of USS probes used in the R-EBUS procedure. Whilst the thicker USS probe (1.7mm) is capable of accommodating larger biopsy instruments, the thinner USS probe could be advanced more peripherally to obtain a biopsy.
Therefore identifying what type of USS probe is better for a given PPL will aid in improving the diagnostic yield.
In this study, investigators compare these two types of probes in the ability to diagnose a PPL.
The biopsy instruments used for both arms are forceps and cytology brush. For the thick USS arm, in addition, an aspiration needle will also be used. (The thin USS guide sheath is too small to accommodate an aspiration needle)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Thick USS (1.7mm) with use of additional aspiration needle
Radial EBUS biopsy
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
Types of Radial Ultrasound probes
The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.
Thin USS (1.4mm)
Radial EBUS biopsy
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
Types of Radial Ultrasound probes
The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.
Interventions
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Radial EBUS biopsy
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
Types of Radial Ultrasound probes
The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.
Eligibility Criteria
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Inclusion Criteria
* Patient judged to be medically stable to give consent for this study.
Exclusion Criteria
* Platelets\<150.
* Hb\> 80g/l
* Liver function tests (AST/ALT) \<2 times upper limit of normal
* Neutrophil count \>1.0
* EGFR \>30ml/kg/min
* On anticoagulation, that cannot be withheld for the procedure, due to medical reasons (e.g. On-clopidogrel with recent drug-eluting stent placement.)
18 Years
90 Years
ALL
No
Sponsors
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Middlemore Hospital, New Zealand
OTHER
Responsible Party
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Samantha Herath
Respiratory Physician
Locations
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Middlemore Hospital, Counties Manakau District Health Board
Auckland, Auckland, New Zealand
Countries
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Facility Contacts
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Other Identifiers
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R- EBUST 2
Identifier Type: -
Identifier Source: org_study_id
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