Skip to content

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001162404
Acronym
CRYSTAL
Enrollment
3
Registered
2025-10-23
Start date
2025-11-03
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

None listed

Brief 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.

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 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.

Sponsors

Westmead Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Diagnosis

Eligibility

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

Inclusion criteria

Adults with a lung lesion requiring biopsy with R-EBUS as determined by the treating respiratory physician.

Exclusion criteria

Radial endobronchial ultrasound biopsy of the same lesion within the last 2 weeks.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026