Cryobiopsy versus open lung biopsy in the diagnosis of interstitial lung disease (COLDICE): protocol of a multicentre study. Issue 1 (21st June 2019)

• Record Type: Journal Article
• Authors: Troy, Lauren K; Grainge, Christopher; Corte, Tamera; Williamson, Jonathan P; Vallely, Michael P; Cooper, Wendy; Mahar, Annabelle M; Lai, Simon; Mulyadi, Ellie; Torzillo, Paul J; Salamonsen, Matthew; Don, Garrick; Myers, Jeffrey; Raghu, Ganesh; Lau, Edmund M T
• Other Names: author non-byline.; Arnold David author non-byline.; Cao Christopher author non-byline.; Cashmore Amy author non-byline.; Cleary Shannon author non-byline.; French Bruce author non-byline.; Geis Monika author non-byline.; Glenn Laura author non-byline.; Harris Benjamin author non-byline.; Hibbert Michael author non-byline.; Ing Alvin author non-byline.; James Allen author non-byline.; Jo Helen E. author non-byline.; Lin Qi Tina author non-byline.; Meredith Graham author non-byline.; Merry Christopher author non-byline.; Ng Benjamin author non-byline.; Phillips Martin author non-byline.; Pudipeddi Anand author non-byline.; Rhodes Jessica author non-byline.; Saghaie Tajalli author non-byline.; Thomas Rajesh author non-byline.; Thomson Claire author non-byline.; Twaddell Scott author non-byline.; Webster Susanne author non-byline.; Wrobel Jeremy author non-byline.; Wu Peter author non-byline.; Oldmeadow Christopher author non-byline.
• Is Part Of: BMJ open respiratory research. Volume 6:Issue 1(2019)
• Publication Date: 2019-06-21
• Subjects: transbronchial lung cryobiopsy -- interstitial lung disease -- surgical lung biopsy -- diagnostic accuracy; Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Diseases -- Treatment -- Periodicals; Respiratory therapy -- Periodicals; 616.2005
• DOI: 10.1136/bmjresp-2019-000443
• Languages: English
• ISSNs: 2052-4439

Abstract

Abstract : Introduction: Transbronchial lung cryobiopsy (TBLC) is a novel, minimally invasive technique for obtaining lung tissue for histopathological assessment in interstitial lung disease (ILD). Despite its increasing popularity, the diagnostic accuracy of TBLC is not yet known. The COLDICE Study (Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE) aims to evaluate the agreement between TBLC and surgical lung biopsy sampled concurrently from the same patients, for both histopathological and multidisciplinary discussion (MDD) diagnoses. Methods and analysis: This comparative, multicentre, prospective trial is enrolling patients with ILD requiring surgical lung biopsy to aid with their diagnosis. Participants are consented for both video-assisted thoracoscopic surgical (VATS) biopsy and TBLC within the same anaesthetic episode. Specimens will be blindly assessed by three expert pathologists both individually and by consensus. Each tissue sample will then be considered in conjunction with clinical and radiological data, within a centralised MDD. Each patient will be presented twice in random order, once with TBLC data and once with VATS data. Meeting participants will be blinded to the method of tissue sampling. The accuracy of TBLC will be assessed by agreement with VATS at (1) histopathological analysis and (2) MDD diagnosis. Data will be collected on interobserver agreement between pathologists, interobserver agreement between MDD participants, and detailed clinical and procedural characteristics. Ethics and dissemination: The study is being conducted in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice and Australian legislation for the ethical conduct of research. Trial registration number: ACTRN12615000718549 .