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Clinical trial of peripheral lung lesion evaluation with radial probe endobronchial ultrasound via an ultraslim bronchoscope and sampling method including a flexible needle

Clinical trial of peripheral lung lesion evaluation with radial probe endobronchial ultrasound via an ultraslim bronchoscope and diagnostic yield with sampling method including a flexible needle

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000703101
Enrollment
56
Registered
2019-05-10
Start date
2019-08-13
Completion date
Unknown
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to compare different methods for the evaluation of peripheral lung lesions. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and plan to undergo endobronchial ultrasound with guide-sheath (EBUS GS) biopsy of a peripheral lung lesion requiring tissue diagnosis at The Prince Charles Hospital. Study details All participants in this study will undergo bronchoscopy, to be performed by a respiratory physician or supervised advanced trainee. If an adequate ultrasound image is obtained, tissue sampling will then be undertaken using two different methods in a random order: standard methods (forcep biopsy and brush) and transbronchial needle aspiration. In patients where no adequate ultrasound image can be obtained, only EBUS GS procedure will be undertaken. Diagnostic methods will be compared for accuracy and participants will be monitored for any adverse events. Costs and timing of the procedure will also be evaluated. It is hoped that this research will add useful information for respiratory physicians in increasing the number of diagnostic procedures performed, which in turn may reduce uncertainty and diagnostic delay.

Interventions

Bronchoscopy (to be performed by respiratory physician or supervised advanced trainee) using Olympus MP-190F ultraslim bronchoscope with radial probe endobronchial ultrasound (rEBUS). Upon identification of adequate ultrasound image (concentric or eccentric), sampling using standard methods (forcep biopsy and brush) plus transbronchial needle aspiration (TBNA) using Olympus PeriView Flex needle. Order of sampling will be randomised 1:1 (TBNA before or after standard methods). 2 stage trial perfo

Bronchoscopy (to be performed by respiratory physician or supervised advanced trainee) using Olympus MP-190F ultraslim bronchoscope with radial probe endobronchial ultrasound (rEBUS). Upon identification of adequate ultrasound image (concentric or eccentric), sampling using standard methods (forcep biopsy and brush) plus transbronchial needle aspiration (TBNA) using Olympus PeriView Flex needle. Order of sampling will be randomised 1:1 (TBNA before or after standard methods). 2 stage trial performed on a participant in a single one hour procedure. Stage 1 - identification of lesion based on ultrasound image Stage 2 - sampling of lesion if identified by ultrasound

Sponsors

Dr Gerard Olive
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Consecutive cases proposed for EBUS GS biopsy of PPL requiring tissue diagnosis at The Prince Charles Hospital • Adult patients >18 years old • Capable of providing written informed consent

Exclusion criteria

• Unacceptably high risk for anaesthetic, bronchoscopy or bleeding • Pregnancy • High risk of pneumothorax with needle sampling eg bullous change surrounding lesion • Biopsy forcep size >1.5mm required

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026