RecruitingACTRN12625001162404

Diagnostic yield of cryobiopsy vs other sampling modalities in Radial Endobronchial Ultrasound lung biopsy: cross-over randomised controlled trial

Diagnostic yield of cryobiopsy vs other sampling modalities in Radial Endobronchial Ultrasound lung biopsy: cross-over randomised controlled trial in adults with a lung lesion.


Sponsor

Westmead Hospital

Enrollment

70 participants

Start Date

Nov 3, 2025

Study Type

Interventional

Conditions

Summary

Brief description of the study purpose This study is testing whether a newer biopsy technique, called cryobiopsy, can be used on its own to accurately diagnose lung nodules. It will also look at whether the order in which different biopsy methods are performed affects the accuracy of the diagnosis. Who is it for? You will be eligible if you are an adult who are scheduled to have a bronchoscopy with radial endobronchial ultrasound (R-EBUS) at Westmead Hospital or Westmead Private Hospital may be able to take part. Study details All participants who are eligible will undergo a bronchoscopy procedure using R-EBUS as part of their routine care. During this procedure, several different biopsy techniques will be performed: up to 6 forceps biopsies, 3 fine needle aspirations, 1 brushing, and up to 5 cryobiopsies. The order of sampling will be randomised. The tissue samples will be examined by pathologists to see which technique provides the most accurate diagnosis. It is hoped this research will show whether cryobiopsy can replace other methods, improving the accuracy and efficiency of diagnosing lung nodules and helping patients receive the right treatment sooner.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a suspicious spot is found in the lung, a bronchoscopy procedure — where a thin flexible camera is passed into the airways — is commonly used to take a tissue sample for diagnosis. There are several ways to take this sample, including tiny forceps, a fine needle, a brush, or a newer method called cryobiopsy, which uses extreme cold to extract a slightly larger piece of tissue. This trial is testing whether cryobiopsy is accurate enough to be used on its own, and whether the order in which different biopsy methods are used affects diagnosis accuracy. During their scheduled bronchoscopy at Westmead Hospital, participants will have samples taken using all of the available methods in a randomised order. Pathologists will then compare the diagnostic accuracy of each method. You may be eligible if you are an adult with a lung lesion that your respiratory doctor has recommended investigating with a radial endobronchial ultrasound (R-EBUS) guided biopsy. People who have had an R-EBUS biopsy of the same lesion within the past two weeks are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pulmonologist performing the radial EBUS procedure will firstly take total of up to 5 cryobiopsies of the lung lesion under investigation. The pulmonologist will then immediately perform the 3x fine n

Pulmonologist performing the radial EBUS procedure will firstly take total of up to 5 cryobiopsies of the lung lesion under investigation. The pulmonologist will then immediately perform the 3x fine needle aspirations, 6x forceps biopsies, 1x brushing of the lung lesion under investigation, without a washout period. The anticipated duration of the procedure is 30 minutes.


Locations(2)

Westmead Hospital - Westmead

NSW, Australia

Westmead Private Hospital - Westmead

NSW, Australia

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ACTRN12625001162404


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