Fluorescein-stained confocal laser endomicroscopy versus conventional frozen section for intraoperative histopathological assessment of intracranial tumors.
Neuro Oncol
; 26(5): 922-932, 2024 May 03.
Article
in En
| MEDLINE
| ID: mdl-38243410
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Brain Neoplasms
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Microscopy, Confocal
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Fluorescein
/
Frozen Sections
Type of study:
Clinical_trials
Limits:
Adult
/
Aged
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Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Neuro Oncol
/
Neuro oncol
/
Neuro-oncology
Journal subject:
NEOPLASIAS
/
NEUROLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Alemania
Country of publication:
Reino Unido