Herlev and Gentofte Hospital, Herlev, Denmark.
Scand J Urol. 2021 Feb;55(1):36-40. doi: 10.1080/21681805.2020.1841285. Epub 2020 Nov 6.
The standard procedure for diagnostics and follow-up for non-muscle invasive bladder cancer (NMIBC) is cystoscopy in the outpatient clinic. Suspicious lesions are biopsied for histopathological assessment. This pilot study aimed to evaluate the ability of Confocal Laser Endomicroscopy (CLE) to rule out High Grade Urothelial Carcinoma (HGUC) to select patients for in-office fulguration.
We performed a prospective non-randomized, single surgeon study. Intraoperative CLE was performed independently by the surgeon and a blinded on-site uropathologist. Following the procedure, a CLE evaluation was performed by another blinded urologist. Lesions were classified as normal/inflammatory, Low Grade Urothelial Carcinoma (LGUC) or HGUC. With the histological evaluations as the gold standard we calculated sensitivity, specificity, PPV and NPV for HGUC and the accuracy for each CLE assessor. The primary outcome was the NPV for HGUC for the surgeon.
Twelve patients with a total of 34 lesions were included. Six lesions were flat and 28 were exophytic. On histopathology, 25 lesions were classified as normal/inflammatory or LGUC, while nine were classified as HGUC. For the surgeon, the uropathologist and the second urologist, the sensitivity was 44%, 78% and 22%, respectively. Specificities for the three observers were 84%, 68% and 96%. This corresponded to PPVs for HGUC of 50%, 47% and 67% and NPV for HGUC of 81%, 89% and 77%.
In our hands the NPV of CLE is not high enough for it to be considered an alternative to histopathological assessment of bladder lesions.
非肌肉浸润性膀胱癌（NMIBC）的标准诊断和随访程序是在门诊进行膀胱镜检查。对可疑病变进行活检以进行组织病理学评估。这项试点研究旨在评估共聚焦激光内窥镜检查（CLE）排除高级尿路上皮癌（HGUC）的能力，以选择适合门诊电灼的患者。
我们进行了一项前瞻性、非随机、单外科医生研究。术中 CLE 由外科医生和一位盲法现场泌尿科病理学家独立进行。手术后，由另一位盲法泌尿科医生进行 CLE 评估。病变分为正常/炎症、低级别尿路上皮癌（LGUC）或 HGUC。以组织学评估为金标准，我们计算了 HGUC 的敏感性、特异性、PPV 和 NPV 以及每位 CLE 评估者的准确性。主要结局是外科医生对 HGUC 的 NPV。
共纳入 12 例患者，共 34 处病变。6 处病变为扁平，28 处为外生性。组织病理学上，25 处病变分为正常/炎症或 LGUC，9 处分为 HGUC。对于外科医生、泌尿科病理学家和第二位泌尿科医生，敏感性分别为 44%、78%和 22%。三位观察者的特异性分别为 84%、68%和 96%。这对应于 HGUC 的 PPV 为 50%、47%和 67%，HGUC 的 NPV 为 81%、89%和 77%。
在我们手中，CLE 的 NPV 不够高，不能作为膀胱病变组织病理学评估的替代方法。
