Bronchoscopy With and Without Needle-based Confocal Laser Endomicroscopy for Peripheral Lung Nodule Diagnosis: Protocol for a Multicenter Randomized Controlled Trial (CLEVER Trial)

What this Trial Is About

Researchers are evaluating whether adding needle-based confocal laser endomicroscopy (nCLE) imaging to standard diagnostic bronchoscopy improves the ability to diagnose suspected malignant peripheral lung nodules. This trial addresses the challenge of diagnosing lung lesions that are difficult to see with regular bronchoscopy, aiming to increase the rate of definitive diagnosis by providing real-time microscopic imaging during tissue sampling. Participants will undergo bronchoscopy that includes standard techniques such as radial endobronchial ultrasound (r-EBUS) and may include fluoroscopy, electromagnetic navigation, virtual bronchoscopy, or ultrathin scopes. The study compares two groups: one receiving conventional bronchoscopy with nCLE imaging integrated before transbronchial needle aspiration (TBNA) to guide needle placement, and a control group receiving conventional bronchoscopy without nCLE. Needle positioning may be adjusted based on nCLE feedback in the study arm to potentially improve diagnostic yield. During the study, participants will have tissue samples collected via bronchoscopy with or without nCLE guidance. Researchers will evaluate diagnostic yield, sensitivity, procedure duration, needle repositioning frequency, fluoroscopy exposure, and complication rates. Follow-up is planned up to six months after bronchoscopy to assess diagnostic outcomes and need for additional diagnostics. The total anticipated study duration is about two years, with ongoing monitoring of safety and diagnostic effectiveness.

Confocal Laser Endomicroscopy VERification