1. Cryobiopsy versus open lung biopsy in the diagnosis of interstitial lung disease (COLDICE): protocol of a multicentre study.
- Author
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Troy LK, Grainge C, Corte T, Williamson JP, Vallely MP, Cooper W, Mahar AM, Lai S, Mulyadi E, Torzillo PJ, Salamonsen M, Don G, Myers J, Raghu G, and Lau EMT
- Subjects
- Cryosurgery, Humans, Biopsy methods, Lung pathology, Lung Diseases, Interstitial pathology, Multicenter Studies as Topic methods, Research Design
- 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., Competing Interests: Competing interests: LKT received study-related unrestricted educational grants or inkind support from the aforementioned commercial entities, on behalf of the COLDICE Investigator Team. MPV sits on the advisory boards of Medtronic and Edwards Lifesciences, and consults for Edwards Lifesciences and Abbott. GR provides consultation for Bellerophon, Biogen, BMS, FibroGen, Gilead, Nitto, Revistan, Promedior, Sanofi, Veracyte, Roche-Genentech, Avalyn and Boehringer Ingelheim. JM is an unpaid collaborator in the Veracyte BRAVE Trial. more...
- Published
- 2019
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