Department of Oral and Maxillofacial Pathology, Faculty of Dentistry, Cairo University, Cairo, Egypt.
Department of Oral and Maxillofacial Pathology, Faculty of Dentistry, Hodeidah University, Hodeidah, Yemen.
BMC Cancer. 2020 Nov 25;20(1):1147. doi: 10.1186/s12885-020-07644-0.
When the resected specimen is sent for intraoperative margin assessment, all margins are grossly checked, and selected margins undergo a frozen section (FS) examination. Therefore, there is a possibility of sampling error. This study evaluated the effectiveness of using toluidine blue (TB) as an intraoperative triage screening tool to detect positive mucosal margins of the resected specimens of oral squamous cell carcinoma (OSCC) and serve as a guide for FS sampling.
Surgical samples of 30 consecutive patients with biopsy-proven OSCC were included in the study. A total of 140 mucosal margins were analyzed intraoperatively by TB and FS, the results were compared with the final histopathology.
Of the 140 examined mucosal tumor margins, 14 stained positives with TB, six were true-positives, eight were false-positives, and there were no false-negatives, as confirmed by final histopathology of the same margins. The diagnostic performance measures were sensitivity 100.0%; specificity 94.0%; positive predictive value (PPV) 42.9%; negative predictive value (NPV) 100.0%; and accuracy 94.3% (95% CI: 89.0-97.5%). For FS, there were three true-positives, three false-negatives, and no false-positives. The diagnostic performance measures were sensitivity 50.0%; specificity 100.0%; PPV 100.0%; NPV 97.8%; and accuracy 97.9% (95% CI: 93.9-99.6%).
TB is less specific but more sensitive than FS for detecting positive mucosal margins of resected OSCC. Screening the tumor mucosal margins with TB before FS sampling may help identify more tumor-bearing margins.
This trial was registered at ClinicalTrials.gov. Registration number: NCT03554967 . Registration date: June 13, 2018.
当切除的标本被送进行术中切缘评估时，所有切缘都进行了大体检查，并对选定的切缘进行了冰冻切片（FS）检查。因此，存在取样误差的可能性。本研究评估了使用甲苯胺蓝（TB）作为术中分诊筛选工具来检测切除的口腔鳞状细胞癌（OSCC）标本阳性黏膜切缘的有效性，并作为 FS 取样的指导。
研究纳入了 30 例经活检证实的 OSCC 患者的手术样本。共对 140 个黏膜肿瘤边缘进行了 TB 和 FS 的术中分析，结果与最终的组织病理学进行了比较。
在 140 个检查的黏膜肿瘤边缘中，14 个用 TB 染色阳性，6 个为真阳性，8 个为假阳性，没有假阴性，这与同一边缘的最终组织病理学结果一致。诊断性能测量指标为敏感性 100.0%；特异性 94.0%；阳性预测值（PPV）42.9%；阴性预测值（NPV）100.0%；和准确性 94.3%（95%CI：89.0-97.5%）。对于 FS，有 3 个真阳性，3 个假阴性，没有假阳性。诊断性能测量指标为敏感性 50.0%；特异性 100.0%；PPV 100.0%；NPV 97.8%；和准确性 97.9%（95%CI：93.9-99.6%）。
TB 检测切除的 OSCC 阳性黏膜切缘的特异性不如 FS，但敏感性更高。在 FS 取样前用 TB 筛查肿瘤黏膜切缘可能有助于识别更多的肿瘤边缘。
该试验在 ClinicalTrials.gov 上注册。注册号：NCT03554967。注册日期：2018 年 6 月 13 日。
