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Itinai.com biomedical laboratory close up still scene close u e4996bf4 1113 41b3 8fdd 0d1e6c918068 3

Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial)

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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