Randomised controlled trial of diagnosis and safety in bronchoscopic versus computed tomography (CT) guided biopsy for peripheral lung nodules.

Randomized pragmatic trial of comprehensive tissue sampling enabled by ultraslim bronchoscopic radial probe endobronchial ultrasound via versus CT-guided transthoracic needle aspiration/biopsy for evaluation of peripheral pulmonary lesions.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621001169831

Acronym

REBUTT

Enrollment

500

Registered

2021-08-30

Start date

2021-09-07

Completion date

2024-09-02

Last updated

2021-09-13

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 bronchoscopic biopsy to CT-guided biopsy for the purposes of evaluating peripheral lung nodules. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a lung lesion in the outer 1/3rd of the lung field measuring between 1-3cm clinically requiring a biopsy. Study details Participants will be randomised (i.e. allocated by chance) to receive either bronchoscopic sampling performed by a respiratory physician or CT-guided biopsy to be performed by an interventional radiologist. Bronchoscopic biopsy will involve the doctor planning the path based upon CT images you have already had, followed by insertion of a thin, flexible tube into the airway, confirmation of position with ultrasound and x-ray and sampling of the lesion using transbronchial needle aspiration as well as forceps and brush. CT-guided biopsy will involve having a needle passed through the chest wall to biopsy the lesion, with guidance of CT images taken immediately before and during the procedure. Diagnostic methods will be compared for accuracy, and all participants will be monitored for complications for 7 days post-procedure. Costs, human resource use, and timing of the procedure will also be evaluated. It is hoped that this research will show that bronchoscopic biopsy is safer, has a comparable diagnostic yield, and is cost-effective compared to CT-guided biopsy for the purposes of evaluating peripheral lung nodules.

Interventions

Bronchoscopic Pre-procedural bronchial branch tracing mapping. To be performed by respiratory physician prior to randomisation. Approximately 5-10 minutes duration. Bronchoscopy performed with ultrathin bronchoscope (Olympus MP190F) with radial probe endobronchial ultrasound (Olympus UM-S20-17S). To be performed by experienced respiratory physician. Sampling to include peripheral transbronchial needle aspiration (pTBNA) with Olympus Periview Flex needle, +/- forceps/brush/wash. Approximate dura

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Presence of peripheral (outer 1/3 of lung field) lung nodule (1-3cm) clinically requiring biopsy in whom both bronchoscopic and CT guided biopsy are considered feasible.

Exclusion criteria

Lesion <1cm diameter Evidence of central (endobronchially visible) lesion Other clinical site of disease more amenable to tissue diagnosis Unacceptably high risk for CT guided biopsy, anaesthetic, bronchoscopy or bleeding. Significant peri-lesional emphysema. Pregnancy

Outcome results