METHODS: Participants scheduled for transurethral resection of papillary bladder tumors were prospectively included for intra-operative fCLE. Exclusion criteria were flat lesions, fluorescein allergy or pregnancy. Two independent observers evaluated fCLE, classifying tumors as low- or high-grade urothelial carcinoma (LGUC/HGUC) or benign. Interobserver agreement was calculated with Cohens kappa (κ) and diagnostic accuracy with 2 × 2 tables. Histopathology was the reference test.
RESULTS: Histopathology of 34 lesions revealed 14 HGUC, 14 LGUC and 6 benign tumors. Diagnostic yield for fCLE was 80-85% with a κ of 0.75. Respectively, sensitivity, specificity, NPV and PPV were: for benign tumors 0-20%, 96-100%, unmeasureable-50% and 87%, for LGUC 57-64%, 41-58%, 44-53% and 54-69% and for HGUC 38-57%, 56-68%, 38-57% and 56-68%, with an interobserver agreement of κ 0.61.
CONCLUSIONS: fCLE is currently insufficient to grade UCB.
方法:计划经尿道膀胱乳头状肿瘤切除术的参与者被前瞻性纳入术中fCLE。排除标准为扁平病变,荧光素过敏或怀孕。两名独立观察者评估了fCLE,将肿瘤分类为低级别或高级别尿路上皮癌(LGUC/HGUC)或良性。使用Cohenskappa(κ)计算观察者之间的一致性,并使用2×2表计算诊断准确性。组织病理学是参考测试。
结果:34个病变的组织病理学显示14个HGUC,14个LGUC和6个良性肿瘤。fCLE的诊断率为80-85%,κ为0.75。分别,灵敏度,特异性,NPV和PPV为:良性肿瘤0-20%,96-100%,无法测量-50%和87%,对于LGUC57-64%,41-58%,44-53%和54-69%,HGUC38-57%,56-68%,38-57%和56-68%,观察者之间的一致性为κ0.61。
结论:fCLE目前不足以对UCB进行分级。