Pulmonary Parenchymal Lesions Clinical Trial
— R-EBUST2Official 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.
| Verified date | April 2016 |
| Source | Middlemore Hospital, New Zealand |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | New Zealand: Ethics Committee |
| Study type | Interventional |
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)
| Status | Recruiting |
| Enrollment | 88 |
| Est. completion date | December 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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:-Unsuitable for flexible bronchoscopy and biopsy - 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.) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Middlemore Hospital, Counties Manakau District Health Board | Auckland |
| Lead Sponsor | Collaborator |
|---|---|
| Middlemore Hospital, New Zealand |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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". |
18 months | No |
| Secondary | 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". | 18 months | No |
| Secondary | Compare the procedure related bleeding and pneumothorax rates between the two arms. | 18 months | No |