Development and validation of a classification and scoring system for the diagnosis of oral squamous cell carcinomas through confocal laser endomicroscopyReport as inadecuate




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Journal of Translational Medicine

, 14:159

First Online: 03 June 2016Received: 13 January 2016Accepted: 20 May 2016DOI: 10.1186-s12967-016-0919-4

Cite this article as: Oetter, N., Knipfer, C., Rohde, M. et al. J Transl Med 2016 14: 159. doi:10.1186-s12967-016-0919-4

Abstract

BackgroundConfocal laser endomicroscopy CLE is an optical biopsy method allowing in vivo microscopic imaging at 1000-fold magnification. It was the aim to evaluate CLE in the human oral cavity for the differentiation of physiological-carcinomatous mucosa and to establish and validate, for the first time, a scoring system to facilitate CLE assessment.

MethodsThe study consisted of 4 phases: 1 CLE-imaging in vivo was performed after the intravenous injection of fluorescein in patients with histologically confirmed carcinomatous oral mucosa; 2 CLE-experts n = 3 verified the applicability of CLE in the oral cavity for the differentiation between physiological and cancerous tissue compared to the gold standard of histopathological assessment; 3 based on specific patterns of tissue changes, CLE-experts n = 3 developed a classification and scoring system DOC-Score to simplify the diagnosis of oral squamous cell carcinomas; 4 validation of the newly developed DOC-Score by non-CLE-experts n = 3; final statistical evaluation of their classification performance comparison to the results of CLE-experts and the histopathological analyses.

ResultsExperts acquired and edited 45 sequences 260 s of physiological and 50 sequences 518 s of carcinomatous mucosa total: 95 sequences-778 s. All sequences were evaluated independently by experts and non-experts based on the newly proposed classification system. Sensitivity 0.953 and specificity 0.889 of the diagnoses by experts as well as sensitivity 0.973 and specificity 0.881 of the non-expert ratings correlated well with the results of the present gold standard of tissue histopathology. Experts had a positive predictive value PPV of 0.905 and a negative predictive value NPV of 0.945. Non-experts reached a PPV of 0.901 and a NPV of 0.967 with the help of the DOC-Score. Inter-rater reliability Fleiss` kappa was 0.73 for experts and 0.814 for non-experts. The intra-rater reliability Cronbach’s alpha of the experts was 0.989 and 0.884 for non-experts.

ConclusionsCLE is a suitable and valid method for experts to diagnose oral cancer. Using the DOC-Score system, an accurate chair-side diagnosis of oral cancer is feasible with comparable results to the gold standard of histopathology—even in daily clinical practice for non-experienced raters.

KeywordsConfocal laser endomicroscopy CLE Oral squamous cell carcinoma OSCC Oral cancer DOC-score Real-time histology Optical biopsy Helmut Neumann and Florian Stelzle contributed equally to this work

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