Bronchoscopy with and without Needle-Based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicentre Randomised Controlled Trial (CLEVER Trial)
Introduction
Despite technological advances, bronchoscopic peripheral lung nodule analysis still faces limitations due to frequent mispositioning. Needle-based confocal laser endomicroscopy (nCLE) provides real-time microscopic feedback on needle positioning, potentially improving sampling location and diagnostic yield. 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 conducted in multiple European countries and the USA. Patients with suspected malignancy in peripheral lung nodules will be included, and randomisation between the two procedures will be performed. The primary outcome is diagnostic yield, with secondary outcomes including diagnostic sensitivity for malignancy, procedure duration, and complications.
Ethics and Dissemination
The trial has received primary approval from the Ethics Committee of the Amsterdam University Medical Center and will be disseminated through publication in a peer-reviewed journal.
Support
Financial and material support for the trial is provided by Mauna Kea Technologies.
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