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

S. van Heumen, T. Kramer, DA. Korevaar, D. Gompelmann, C. Bal, J. Hetzel, K. Jahn, V. Poletti, C. Ravaglia, A. Sadoughi, G. Stratakos, K. Bakiri, E. Koukaki, N. Anagnostopoulos, J. Votruba, Z. Šestáková, MA. Heuvelmans, JMA. Daniels, DM. de...

. 2024 ; 14 (7) : e081148. [pub] 20240704

Language English Country England, Great Britain

Document type Journal Article, Clinical Trial Protocol, Multicenter Study, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc24019809

INTRODUCTION: Despite 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 ANALYSIS: This 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 DISSEMINATION: Primary approval by the Ethics Committee of the Amsterdam University Medical Center. Dissemination involves publication in a peer-reviewed journal. SUPPORT: Financial and material support from Mauna Kea Technologies. TRIAL REGISTRATION NUMBER: NCT06079970.

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$a van Heumen, Saskia $u Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands $1 https://orcid.org/0000000182334677
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$a INTRODUCTION: Despite 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 ANALYSIS: This 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 DISSEMINATION: Primary approval by the Ethics Committee of the Amsterdam University Medical Center. Dissemination involves publication in a peer-reviewed journal. SUPPORT: Financial and material support from Mauna Kea Technologies. TRIAL REGISTRATION NUMBER: NCT06079970.
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$a Kramer, Tess $u Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands $1 https://orcid.org/0000000224132329
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$a Korevaar, Daniël A $u Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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$a Gompelmann, Daniela $u Division of Pulmonology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
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$a Bal, Christina $u Division of Pulmonology, Department of Internal Medicine II, Medical University of Vienna, Vienna, Austria
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$a Hetzel, Juergen $u Department of Pneumology, University Hospital Basel, Basel, Switzerland
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$a Jahn, Kathleen $u Department of Pneumology, University Hospital Basel, Basel, Switzerland
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$a Poletti, Venerino $u Pulmonary Unit, Department of Thoracic Diseases, GB Morgagni-Pierantoni Hospital, Forli, Italy
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$a Ravaglia, Claudia $u Pulmonary Unit, Department of Thoracic Diseases, GB Morgagni-Pierantoni Hospital, Forli, Italy
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$a Sadoughi, Ali $u Department of Pulmonary Medicine, Montefiore Medical Center Einstein Campus, New York, New York, USA
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$a Stratakos, Grigoris $u Interventional Pulmonology Unit of the 1st Respiratory Medicine Department, "Sotiria" Hospital, National and Kapodistrian University of Athens, Athens, Greece
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$a Bakiri, Katerina $u Interventional Pulmonology Unit of the 1st Respiratory Medicine Department, "Sotiria" Hospital, National and Kapodistrian University of Athens, Athens, Greece
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$a Koukaki, Evangelia $u Interventional Pulmonology Unit of the 1st Respiratory Medicine Department, "Sotiria" Hospital, National and Kapodistrian University of Athens, Athens, Greece
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$a Daniels, Johannes M A $u Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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$a de Bruin, Daniel M $u Department of Biomedical Engineering and Physics, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands $u Imaging and Biomarkers, Cancer Center Amsterdam, Amsterdam, The Netherlands
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$a Bonta, Peter I $u Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
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