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 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 improvin...
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BMJ Publishing Group
2024-07-01
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| author | Marjolein A Heuvelmans Kathleen Jahn Jouke T Annema Venerino Poletti Christina Bal Daniela Gompelmann Daniël A Korevaar Juergen Hetzel Claudia Ravaglia Grigoris Stratakos Peter I Bonta Tess Kramer Evangelia Koukaki Saskia van Heumen Ali Sadoughi Katerina Bakiri Nektarios Anagnostopoulos Jiří Votruba Zuzana Šestáková Johannes M.A. Daniels Daniel M de Bruin |
| author_facet | Marjolein A Heuvelmans Kathleen Jahn Jouke T Annema Venerino Poletti Christina Bal Daniela Gompelmann Daniël A Korevaar Juergen Hetzel Claudia Ravaglia Grigoris Stratakos Peter I Bonta Tess Kramer Evangelia Koukaki Saskia van Heumen Ali Sadoughi Katerina Bakiri Nektarios Anagnostopoulos Jiří Votruba Zuzana Šestáková Johannes M.A. Daniels Daniel M de Bruin |
| author_sort | Marjolein A Heuvelmans |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3d7a81178e2540cca68bc5db5fded5f9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-3d7a81178e2540cca68bc5db5fded5f92025-08-20T03:52:14ZengBMJ Publishing GroupBMJ Open2044-60552024-07-0114710.1136/bmjopen-2023-081148Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial)Marjolein A Heuvelmans0Kathleen Jahn1Jouke T Annema2Venerino Poletti3Christina Bal4Daniela Gompelmann5Daniël A Korevaar6Juergen Hetzel7Claudia Ravaglia8Grigoris Stratakos9Peter I Bonta10Tess Kramer11Evangelia Koukaki12Saskia van Heumen13Ali Sadoughi14Katerina Bakiri15Nektarios Anagnostopoulos16Jiří Votruba17Zuzana Šestáková18Johannes M.A. Daniels19Daniel M de Bruin20Department of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Pneumology, University Hospital Basel, Basel, SwitzerlandDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsPulmonary Unit, Department of Thoracic Diseases, GB Morgagni-Pierantoni Hospital, Forli, ItalyDivision of Pulmonology, Department of Internal Medicine II, Medical University of Vienna, Vienna, AustriaDivision of Pulmonology, Department of Internal Medicine II, Medical University of Vienna, Vienna, AustriaDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Pneumology, University Hospital Basel, Basel, SwitzerlandPulmonary Unit, Department of Thoracic Diseases, GB Morgagni-Pierantoni Hospital, Forli, ItalyInterventional Pulmonology Unit of the 1st Respiratory Medicine Department, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, GreeceDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsInterventional Pulmonology Unit of the 1st Respiratory Medicine Department, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, GreeceDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Pulmonary Medicine, Montefiore Medical Center Einstein Campus, New York, New York, USAInterventional Pulmonology Unit of the 1st Respiratory Medicine Department, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, GreeceInterventional Pulmonology Unit of the 1st Respiratory Medicine Department, Sotiria Hospital, National and Kapodistrian University of Athens, Athens, Greece1st Department of Tuberculosis and Respiratory Diseases, General University Hospital in Prague, Prague, Czech Republic1st Department of Tuberculosis and Respiratory Diseases, General University Hospital in Prague, Prague, Czech RepublicDepartment of Pulmonary Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsDepartment of Biomedical Engineering and Physics, Amsterdam UMC, University of Amsterdam, Amsterdam, The NetherlandsIntroduction 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.https://bmjopen.bmj.com/content/14/7/e081148.full |
| spellingShingle | Marjolein A Heuvelmans Kathleen Jahn Jouke T Annema Venerino Poletti Christina Bal Daniela Gompelmann Daniël A Korevaar Juergen Hetzel Claudia Ravaglia Grigoris Stratakos Peter I Bonta Tess Kramer Evangelia Koukaki Saskia van Heumen Ali Sadoughi Katerina Bakiri Nektarios Anagnostopoulos Jiří Votruba Zuzana Šestáková Johannes M.A. Daniels Daniel M de Bruin Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) BMJ Open |
| title | Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) |
| title_full | Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) |
| title_fullStr | Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) |
| title_full_unstemmed | Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) |
| title_short | Bronchoscopy with and without needle-based confocal laser endomicroscopy for peripheral lung nodule diagnosis: protocol for a multicentre randomised controlled trial (CLEVER trial) |
| title_sort | bronchoscopy with and without needle based confocal laser endomicroscopy for peripheral lung nodule diagnosis protocol for a multicentre randomised controlled trial clever trial |
| url | https://bmjopen.bmj.com/content/14/7/e081148.full |
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