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The COLDICE Trial: Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE

In patients with interstitial lung disease requiring histopathologic evaluation for diagnosis, are the transbronchial lung cryobiopsy (TBLC) and the gold-standard video-assisted thoracoscopic surgical (VATS) lung biopsy, similar in their diagnostic yield?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000718549
Acronym
COLDICE
Enrollment
65
Registered
2015-07-10
Start date
2016-03-15
Completion date
2019-04-15
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The transbronchial lung cryobiopsy is a new, minimally invasive technique for obtaining lung tissue to diagnose ILD. In order to determine the place of cryobiopsy in ILD diagnostic algorithms and international guidelines, it is crucial that this procedure is validated against the current gold-standard practice, the VATS biopsy. This study brings together a team of leading proceduralists, ILD specialists and histopathologists from across Australia, with consultative input from international leaders in the field. The main objective of this project is to determine the role of cryobiopsy in the diagnosis of ILD.

Interventions

Transbronchial lung cryobiopsy - a recently developed technique involving the bronchoscopic insertion of a frozen-tipped probe into peripheral airways for extraction of lung tissue specimens for diagnostic purposes. This will take between 30-45 minutes in most cases.

Sponsors

Lauren Troy
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Patients assessed as requiring histopathology for the diagnosis of their ILD (at specialist multidisciplinary team meetings), and considered suitable for VATS lung biopsy.

Exclusion criteria

* Age > 80 * Resting oxyhaemoglobin saturation under 90% * Platelets less than 100 * INR > 1.5 * Advanced comorbidities (including poorly controlled systemic hypertension, congestive cardiac failure, unstable angina, significant stroke). * History of of adverse reaction to general anaesthesia * Inability to provide informed consent * Systolic pulmonary artery pressure over 40mmHg on echocardiogram or evidence of right ventricular dysfunction * Inability to withhold anti-platelet therapy (eg aspirin or clopidogrel)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 2, 2026