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

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

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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Obtaining a tissue sample to diagnose parenchymal lung lesions (PPL) suspected of cancerous origin is of utmost importance. Due to it's markedly favourable safety profile, a bronchoscopic biopsy method called Radial EBUS is becoming increasingly popular. However, a meta-analysis reports the success rate of Radial EBUS in diagnosis is 73%, which in comparison to CT guided biopsy which is the gold standard in diagnosing PPL (90% success rate), is sub-optimal.

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)

Detailed Description

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Conditions

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Pulmonary Parenchymal Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Thick USS (1.7mm) with use of additional aspiration needle

Group Type ACTIVE_COMPARATOR

Radial EBUS biopsy

Intervention Type PROCEDURE

Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.

Types of Radial Ultrasound probes

Intervention Type DEVICE

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)

Group Type ACTIVE_COMPARATOR

Radial EBUS biopsy

Intervention Type PROCEDURE

Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.

Types of Radial Ultrasound probes

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient referred for R-EBUS as per routine management.
* Patient judged to be medically stable to give consent for this study.

Exclusion Criteria

* INR\>1.5
* 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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Middlemore Hospital, New Zealand

OTHER

Sponsor Role lead

Responsible Party

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Samantha Herath

Respiratory Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Middlemore Hospital, Counties Manakau District Health Board

Auckland, Auckland, New Zealand

Site Status RECRUITING

Countries

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New Zealand

Facility Contacts

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Samantha Herath

Role: primary

+64211298979

Other Identifiers

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R- EBUST 2

Identifier Type: -

Identifier Source: org_study_id

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