United States, Austria, Czechia208 participantsStarted 2023-10-18
Plain-language summary
The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy.
The main question\[s\] it aims to answer are:
To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure).
Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age
✓. Suspected malignant peripheral lung lesion with an indication for a bronchoscopic diagnostic work-up as determined by the attending physician or tumor board. Peripheral pulmonary lesions are defined as lesions located beyond the visible segmental bronchi, not detectable by regular flexible bronchoscopy
✓. Bronchus sign on pre-procedural CT or estimated confidence for successful navigation to the nodule resulting in a r-EBUS signal
✓. Solid part of the lesion must be ≧10 mm
✓. Largest dimension of lesion size on CT ≦30 mm (long-axis)
✓. Ability to understand and willingness to sign a written informed consent
Exclusion criteria
✕. Inability or non-willingness to provide informed consent
✕. Endobronchial visible malignancy on bronchoscopic inspection
✕. Target lesion within reach of the linear EBUS scope
What they're measuring
1
Diagnostic yield (intermediate definition)
Timeframe: After all patients have been included and followed up to 6 months after bronchoscopy (expected total time frame 2 years)
Trial details
NCT IDNCT06079970
SponsorAmsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)