학술논문
Fluorescein-stained confocal laser endomicroscopy versus conventional frozen section for intraoperative histopathological assessment of intracranial tumors.
Document Type
Academic Journal
Author
Wagner A; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Brielmaier MC; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Kampf C; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Baumgart L; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Aftahy AK; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Meyer HS; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Kehl V; Institute for AI and Informatics in Medicine & Muenchner Studienzentrum (MSZ), Technical University Munich School of Medicine, Munich, Germany.; Höhne J; Department of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.; Department of Neurosurgery, Paracelsus Medical University, Nürnberg, Germany.; Schebesch KM; Department of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.; Department of Neurosurgery, Paracelsus Medical University, Nürnberg, Germany.; Schmidt NO; Department of Neurosurgery, Regensburg University Hospital, Regensburg, Germany.; Zoubaa S; Department of Neuropathology, Regensburg University Hospital, Regensburg, Germany.; Riemenschneider MJ; Department of Neuropathology, Regensburg University Hospital, Regensburg, Germany.; Ratliff M; Department of Neurosurgery, University Hospital Mannheim, Mannheim, Germany.; Enders F; Department of Neurosurgery, University Hospital Mannheim, Mannheim, Germany.; von Deimling A; Department of Neuropathology, University Hospital Heidelberg and CCU Neuropathology, German Cancer Center (DKFZ), Heidelberg, Germany.; Liesche-Starnecker F; Department of Neuropathology, Pathology, Medical Faculty, University Hospital Augsburg, Augsburg, Germany.; Delbridge C; Department of Neuropathology, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Schlegel J; Department of Neuropathology, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Meyer B; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Gempt J; Department of Neurosurgery, Klinikum rechts der Isar Technical University Munich School of Medicine, Munich, Germany.; Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 100887420 Publication Model: Print Cited Medium: Internet ISSN: 1523-5866 (Electronic) Linking ISSN: 15228517 NLM ISO Abbreviation: Neuro Oncol Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The aim of this clinical trial was to compare Fluorescein-stained intraoperative confocal laser endomicroscopy (CLE) of intracranial lesions and evaluation by a neuropathologist with routine intraoperative frozen section (FS) assessment by neuropathology.
Methods: In this phase II noninferiority, prospective, multicenter, nonrandomized, off-label clinical trial (EudraCT: 2019-004512-58), patients above the age of 18 years with any intracranial lesion scheduled for elective resection were included. The diagnostic accuracies of both CLE and FS referenced with the final histopathological diagnosis were statistically compared in a noninferiority analysis, representing the primary endpoint. Secondary endpoints included the safety of the technique and time expedited for CLE and FS.
Results: A total of 210 patients were included by 3 participating sites between November 2020 and June 2022. Most common entities were high-grade gliomas (37.9%), metastases (24.1%), and meningiomas (22.7%). A total of 6 serious adverse events in 4 (2%) patients were recorded. For the primary endpoint, the diagnostic accuracy for CLE was inferior with 0.87 versus 0.91 for FS, resulting in a difference of 0.04 (95% confidence interval -0.10; 0.02; P = .367). The median time expedited until intraoperative diagnosis was 3 minutes for CLE and 27 minutes for FS, with a mean difference of 27.5 minutes (standard deviation 14.5; P < .001).
Conclusions: CLE allowed for a safe and time-effective intraoperative histological diagnosis with a diagnostic accuracy of 87% across all intracranial entities included. The technique achieved histological assessments in real time with a 10-fold reduction of processing time compared to FS, which may invariably impact surgical strategy on the fly.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.)
Methods: In this phase II noninferiority, prospective, multicenter, nonrandomized, off-label clinical trial (EudraCT: 2019-004512-58), patients above the age of 18 years with any intracranial lesion scheduled for elective resection were included. The diagnostic accuracies of both CLE and FS referenced with the final histopathological diagnosis were statistically compared in a noninferiority analysis, representing the primary endpoint. Secondary endpoints included the safety of the technique and time expedited for CLE and FS.
Results: A total of 210 patients were included by 3 participating sites between November 2020 and June 2022. Most common entities were high-grade gliomas (37.9%), metastases (24.1%), and meningiomas (22.7%). A total of 6 serious adverse events in 4 (2%) patients were recorded. For the primary endpoint, the diagnostic accuracy for CLE was inferior with 0.87 versus 0.91 for FS, resulting in a difference of 0.04 (95% confidence interval -0.10; 0.02; P = .367). The median time expedited until intraoperative diagnosis was 3 minutes for CLE and 27 minutes for FS, with a mean difference of 27.5 minutes (standard deviation 14.5; P < .001).
Conclusions: CLE allowed for a safe and time-effective intraoperative histological diagnosis with a diagnostic accuracy of 87% across all intracranial entities included. The technique achieved histological assessments in real time with a 10-fold reduction of processing time compared to FS, which may invariably impact surgical strategy on the fly.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology.)