Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease
COLDICE trial design and results
Design
Prospective comparative study with each patient acting as their own control
Treatment
Transbronchial lung cryobiopsy
Control
Surgical lung biopsy in the same patient during the same anaesthetic
Population
65 patients, 31 men and 34 women, mean age 66.1 years, mean FVC 83.7% predicted, DLCO 63.4% predicted
Follow-up
Diagnostic study
Primary endpoint
Agreement between cryobiopsy and surgical lung biopsy for histopathological pattern and multidisciplinary diagnosis
Result
Cryobiopsy samples averaged 7.1 mm against 46.5 mm for surgical biopsy, yet agreement was high for both histopathological interpretation and multidisciplinary diagnosis. Cryobiopsy diagnoses made with high confidence showed excellent concordance with surgical biopsy diagnoses.
Secondary endpoints
Diagnostic confidence, complications
High levels of agreement between TBLC and SLB for both histopathological interpretation and MDD diagnoses were shown. The TBLC MDD diagnoses made with high confidence were particularly reliable, showing excellent concordance with SLB MDD diagnoses.
The trial authors, in the published abstract
How it has aged
The design is the strength: same patient, same anaesthetic, both procedures — which removes the selection bias that plagued earlier cryobiopsy series. The qualifier matters though, and the authors state it: concordance is excellent when confidence is high, and less so when it is not. COLD later tested the strategy rather than the accuracy.
Publications
Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study
Troy LK, Grainge C, Corte TJ, et al. Diagnostic accuracy of transbronchial lung cryobiopsy for interstitial lung disease diagnosis (COLDICE): a prospective, comparative study. Lancet Respir Med 2020 Feb;8(2):171-181.
High agreement with surgical lung biopsy despite far smaller samples
Concordance excellent specifically for high-confidence diagnoses
Paired design with both procedures in the same patient