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

IntroductionDespite 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...

Celý popis

Uložené v:
Podrobná bibliografia
Vydané v:BMJ open Ročník 14; číslo 7; s. e081148
Hlavní autori: van Heumen, Saskia, Kramer, Tess, Korevaar, Daniël A, Gompelmann, Daniela, Bal, Christina, Hetzel, Juergen, Jahn, Kathleen, Poletti, Venerino, Ravaglia, Claudia, Sadoughi, Ali, Stratakos, Grigoris, Bakiri, Katerina, Koukaki, Evangelia, Anagnostopoulos, Nektarios, Votruba, Jiří, Šestáková, Zuzana, Heuvelmans, Marjolein A, Daniels, Johannes M.A., de Bruin, Daniel M, Bonta, Peter I, Annema, Jouke T
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: England British Medical Journal Publishing Group 04.07.2024
BMJ Publishing Group LTD
BMJ Publishing Group
Edícia:Protocol
Predmet:
Biopsy
Bronchoscopy
Bronchoscopy - methods
Cancer therapies
Clinical Trial
Cytopathology
Diagnostic Imaging
Feedback
Humans
Informed consent
Lasers
Lung - diagnostic imaging
Lung - pathology
Lung cancer
Lung Neoplasms - diagnosis
Lung Neoplasms - diagnostic imaging
Lung Neoplasms - pathology
Medical diagnosis
Medical screening
Microscopy, Confocal - methods
Multicenter Studies as Topic
Needles
Patients
Randomized Controlled Trials as Topic
Respiratory Medicine
Respiratory tract tumours
Solitary Pulmonary Nodule - diagnosis
Solitary Pulmonary Nodule - diagnostic imaging
Solitary Pulmonary Nodule - pathology
Success
Ultrasonic imaging
Diagnostic Imaging
Respiratory tract tumours
Cytopathology
Clinical Trial
Biopsy
ISSN:2044-6055, 2044-6055
On-line prístup:Získať plný text
Tagy: Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
Popis
Shrnutí:IntroductionDespite 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 analysisThis 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 disseminationPrimary approval by the Ethics Committee of the Amsterdam University Medical Center. Dissemination involves publication in a peer-reviewed journal.SupportFinancial and material support from Mauna Kea Technologies.Trial registration numberNCT06079970.
Bibliografia:Protocol
ObjectType-Article-2
SourceType-Scholarly Journals-1
content type line 14
ObjectType-Feature-3
ObjectType-Evidence Based Healthcare-1
ObjectType-Undefined-1
content type line 23
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2023-081148