None listed
Conditions
Brief summary
The proposed single-arm study will investigate the feasibility and utility of CLE and radial EBUS for the detection of lung parenchymal abnormalities in people with ILD. The study will establish the diagnostic yield of radial EBUS and CLE in detection of parenchymal abnormalities in patients with radiologic ILD, by comparing these techniques to the gold standard test of histology, as well as high-resolution CT chest imaging. Real-time assessment and recording of video imaging for later, de-identified review will also permit determination of intra-observer and inter-observer variability. Additional secondary outcomes include safety.
Interventions
Interventional - single-arm study Exposure: endoscopic imaging of the lung parenchyma using confocal laser endomicroscopy (CLE) and radial endobronchial ultrasound (radial EBUS) in unclassifiable interstitial lung disease (ILD) prior to undergoing transbronchial lung cryobiopsy (TBLC). • Patients with unclassifiable ILD who have been referred for TBLC will be enrolled. • All procedures will be performed by two respiratory physician bronchoscopists, one of whom has extensive experience in the performance of TBLC. • Participant recruitment is estimated to take up to 6 months in duration. • Participants will undergo a TBLC procedure following standard practice at the treating institution (compliant with international expert guidelines on the performance of cryobiopsy). Three ipsilateral target sites for TBLC will be selected prior to the procedure after review of CT imaging and discussion at an interstitial lung disease multidisciplinary meeting. They will be performed under fluoroscopy guidance and general anaesthesia. • Prior to the biopsies being taken, all the target sites will be viewed with (1) radial EBUS, followed by (2) CLE. The recorded images will not be used to guide the site of biopsy selection. Images will be compared to final histologic findings. • The radial EBUS component will involve interrogation of the target site distal airway (approximately the distal 3cm) with the EBUS probe. CLE will involve interrogation of the same airway segment with a thin, flexible endomicroscopy probe that is inserted through the working channel of the bronchoscope. The position of both probes will be confirmed on fluoroscopy. • The combined time of radial EBUS and CLE in addition to the standard TBLC is estimated to be 15 minutes. The baseline average duration of TBLC is 45 minutes. • Adherence to the intervention protocol will be documented by in the record of the crobiopsy session, including identification of all biopsy sites with and the related imaging findings from the various imaging modalities. • No specific contrast dyes or other markers will be administered to participants. Patients with unclassifiable ILD who have been referred for TBLC will be enrolled. Three target sites for biopsy will be examined with radial EBUS then CLE prior to TBLC at the same location under fluoroscopy guidance. Imaging findings on radial EBUS and CLE will be compared to histologic findings.
Sponsors
Study design
Eligibility
Inclusion criteria
- Adults aged 18 years or older - Working diagnosis of unclassifiable interstitial lung disease or a low confidence diagnosis - Referred for cryobiopsy following discussion at an ILD multidisciplinary meeting
Exclusion criteria
• Reduced lung function (FVC less than 50% predicted; or FEV1 less than 50% predicted or less than 0.8L; or DLCO less than 50% predicted or less than 35 units) • Uncontrolled bleeding diathesis • American Society of Anesthesiology Status of III or higher • Hypoxaemia (PaO2 less than 55 to 60mmHg on room air or while receiving 2L/minute nasal oxygen) • Pulmonary hypertension (sPAP greater than 50mmHg) • Body mass index greater than 35kg/m2 • Inability to give informed consent • Vulnerable population (inability to understand English, pregnant women, prisoner)