In:
BMJ Open, BMJ, Vol. 14, No. 7 ( 2024-07), p. e081148-
Abstract:
Despite many technological advances, the diagnostic yield of
bronchoscopic peripheral lung nodule analysis remains limited due to frequent mispositioning. Needle-based confocal laser endomicroscopy
(nCLE) enables real-time microscopic feedback on needle positioning, potentially improving the sampling location and diagnostic yield.
Previous studies have defined and validated nCLE criteria for malignancy, airway and lung parenchyma. Larger studies demonstrating the
effect of nCLE on diagnostic yield are lacking. We aim to investigate if nCLE-imaging integrated with conventional bronchoscopy results in a
higher diagnostic yield compared with conventional bronchoscopy without nCLE. Methods and analysis This is a parallel-group randomised controlled trial. Recruitment is
performed at pulmonology outpatient clinics in universities and general hospitals in six different European countries and one hospital in the
USA. Consecutive patients with a for malignancy suspected peripheral lung nodule (10–30 mm) with an indication for diagnostic bronchoscopy
will be screened, and 208 patients will be included. Web-based randomisation (1:1) between the two procedures will be performed. The
primary outcome is diagnostic yield. Secondary outcomes include diagnostic sensitivity for malignancy, needle repositionings, procedure
and fluoroscopy duration, and complications. Pathologists will be blinded to procedure type; patients and endoscopists will not. Ethics and dissemination Primary approval by the Ethics Committee of the Amsterdam University
Medical Center. Dissemination involves publication in a peer-reviewed journal. Support Financial and material support from Mauna Kea Technologies. Trial registration number NCT06079970 .
Type of Medium:
Online Resource
ISSN:
2044-6055
,
2044-6055
DOI:
10.1136/bmjopen-2023-081148
DOI:
10.1136/bmjopen-2023-081148.supp1
Language:
English
Publisher:
BMJ
Publication Date:
2024
detail.hit.zdb_id:
2599832-8
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