Pulmonary Parenchymal LesionsR-EBUST2NCT02739126
Comparing the Diagnostic Yield of Radial EBUS Guided Biopsies When Using a Thick (1.7mm) Vs. Thin (1.4 mm) USS Probe.
A study testing Radial EBUS biopsy and Types of Radial Ultrasound probes in people with Pulmonary Parenchymal Lesions, run by Middlemore Hospital, New Zealand at 1 site in New Zealand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Parenchymal Lesions
- What is being tested?
- Radial EBUS biopsy and Types of Radial Ultrasound probes
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jan 2015to Dec 2017
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred for R-EBUS as per routine management.
- Patient judged to be medically stable to give consent for this study.
- Exclusion Criteria:-Unsuitable for flexible bronchoscopy and biopsy
- INR>1.5
- Platelets<150.
- Hb> 80g/l
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- 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.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Middlemore Hospital, Counties Manakau District Health Board
Auckland, Auckland, 2025
Samantha Herath, +64211298979, scherath@yahoo.com
About this study
Official title: Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick (1.7mm) With an Aspiration Needle Biopsy Vs. a Thin USS Probe (1.4mm), in Peripheral Lung Lesions.
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.
Read more
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)
- Conditions
- Pulmonary Parenchymal Lesions
- Being tested
- Radial EBUS biopsy, Types of Radial Ultrasound probes
- Keywords
- Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial EBUS biopsyProcedure or surgery
Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
Types of Radial Ultrasound probesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Thick USS (1.7mm) with use of additional aspiration needle | Active comparator | Not described Receives: Procedure: Radial EBUS biopsy; Device: Types of Radial Ultrasound probes |
| Thin USS (1.4mm) | Active comparator | Not described Receives: Procedure: Radial EBUS biopsy; Device: Types of Radial Ultrasound probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as
- To what biopsies give a diagnosis of malignancy and
- Will decide what is the best sample in comparing all samples from both arms defined as " the highest number of malignant cells/hpf".
Measured: 18 months
Secondary outcomes (2)
Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as to what is the best sample defined as " the sample most suitable for EGFR mutation analysis".
Measured: 18 months
Compare the procedure related bleeding and pneumothorax rates between the two arms.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Parenchymal LesionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middlemore Hospital, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Herath, Middlemore Hospital, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739126
- Sponsor's protocol ID
- R- EBUST 2
- Acronym
- R-EBUST2
- Status last verified
- Apr 2016
- First submitted
- 19 Feb 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Diagnostic Yield of Radial Endo-Bronchial Ultra-Sound Guided Biopsy When Using a Thick (1.7mm) With an Aspiration Needle Biopsy Vs. a Thin USS Probe (1.4mm), in Peripheral Lung Lesions.
- ClinicalTrials.gov ID
- NCT02739126
- Acronym / sponsor ID
- R-EBUST2 / R- EBUST 2
- Conditions
- Pulmonary Parenchymal Lesions
- Keywords
- Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Middlemore Hospital, New ZealandUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Apr 2016 (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.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thick USS (1.7mm) with use of additional aspiration needle | Active comparator | Procedure: Radial EBUS biopsy, Device: Types of Radial Ultrasound probes |
| Thin USS (1.4mm) | Active comparator | Procedure: Radial EBUS biopsy, Device: Types of Radial Ultrasound probes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient referred for R-EBUS as per routine management.
- Patient judged to be medically stable to give consent for this study.
- Exclusion Criteria:-Unsuitable for flexible bronchoscopy and biopsy
- INR>1.5
- Platelets<150.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Radial EBUS biopsyRadial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass. | Procedure or surgery | Thick USS (1.7mm) with use of additional aspiration needle, Thin USS (1.4mm) |
| Types of Radial Ultrasound probesThe Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter. | Device | Thick USS (1.7mm) with use of additional aspiration needle, Thin USS (1.4mm) |
Primary outcome
Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath.
Time frame: 18 months
A blinded pathologist will assess all samples from the thick USS arm and all samples from the thin USS arm separately and come to a conclusion as 1. To what biopsies give a diagnosis of malignancy and 2. Will decide what is the best sample in comparing all samples from both arms defined as " the highest number of malignant cells/hpf".
2 secondary outcomes
Suitability of the biopsy samples from each arm to perform EGFR mutation testing.
Time frame: 18 months
Compare the procedure related bleeding and pneumothorax rates between the two arms.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: No
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.
Middlemore Hospital, Counties Manakau District Health Board
Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial EBUS biopsy and Types of Radial Ultrasound probes in people with Pulmonary Parenchymal Lesions, run by Middlemore Hospital, New Zealand at 1 site in New Zealand.
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 10 inclusion and 0 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 15 Apr 2016. 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 New Zealand. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the diagnostic yield (sensitivity) from the biopsies taken using the thick USS and Guide sheath to that of biopsies taken using the thin USS and Guide sheath. (time frame: 18 months). 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 15 Apr 2016.