Endoscopy Unit, Department of Gastroenterology, Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas da Universidade de São Paulo (ICESP-HCFMUSP), São Paulo, Brazil.
Digestive Surgery and Colorectal Division, Department of Gastroenterology, Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas da Universidade de São Paulo (ICESP-HCFMUSP), São Paulo, Brazil.
J Gastrointest Surg. 2023 Sep;27(9):1903-1912. doi: 10.1007/s11605-023-05732-7. Epub 2023 Jun 8.
Watch-and-wait strategy has been increasingly accepted for patients with clinical complete response (cCR) after multimodal treatment for locally advanced rectal adenocarcinoma. Close follow-up is essential to the early detection of local regrowth. It was previously demonstrated that probe-based confocal laser endomicroscopy (pCLE) scoring using the combination of epithelial and vascular features might improve the diagnostic accuracy of cCR.
To validate the pCLE scoring system in the assessment of patients with cCR after neoadjuvant chemoradiotherapy (nCRxt) for advanced rectal adenocarcinoma.
Digital rectal examination, pelvic magnetic resonance imaging (MRI), and pCLE were performed in 43 patients with cCR, who presented either a scar (N = 33; 76.7%) or a small ulcer with no signs of tumor, and/or biopsy negative for malignancy (N = 10; 23.3%).
Twenty-five (58.1%) patients were men, and the mean age was 58.4 years. During the follow-up, 12/43 (27.9%) patients presented local regrowth and underwent salvage surgery. There was an association between pCLE diagnostic scoring and final histological report (for patients who underwent surgical resection) or final diagnosis at the latest follow-up (p = 0.0001), while this association was not observed with MRI (p = 0.49). pCLE sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 93.5%, 80%, 88.9%, and 86%, respectively. MRI sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were 66.7%, 48.4%, 66.7%, 78.9%, and 53.5%, respectively.
pCLE scoring system based on epithelial and vascular features improved the diagnosis of sustained cCR and might be recommended during follow-up. pCLE might add some valuable contribution for identifying local regrowth. Trial Registration This protocol was registered at the Clinical Trials (ClinicalTrials.gov identifier NCT02284802).
多模态治疗局部晚期直肠腺癌后，对于临床完全缓解（cCR）的患者，观察等待策略已被越来越多地接受。密切随访对于早期检测局部复发至关重要。先前已经证明，使用上皮和血管特征组合的基于探针的共聚焦激光内窥镜检查（pCLE）评分可能会提高 cCR 的诊断准确性。
验证 pCLE 评分系统在评估接受新辅助放化疗（nCRxt）治疗的晚期直肠腺癌后 cCR 患者中的作用。
对 43 例临床完全缓解的患者进行直肠指诊、盆腔磁共振成像（MRI）和 pCLE 检查，这些患者表现为瘢痕（33 例；76.7%）或小溃疡且无肿瘤迹象，和/或活检无恶性肿瘤（10 例；23.3%）。
25 例（58.1%）患者为男性，平均年龄为 58.4 岁。在随访期间，12/43（27.9%）例患者出现局部复发并接受了挽救性手术。pCLE 诊断评分与最终组织学报告（接受手术切除的患者）或最新随访时的最终诊断之间存在关联（p=0.0001），而与 MRI 无关联（p=0.49）。pCLE 的敏感性、特异性、阳性预测值、阴性预测值和准确性分别为 66.7%、93.5%、80%、88.9%和 86%。MRI 的敏感性、特异性、阳性预测值、阴性预测值和准确性分别为 66.7%、48.4%、66.7%、78.9%和 53.5%。
基于上皮和血管特征的 pCLE 评分系统提高了持续 cCR 的诊断准确性，并且可能在随访期间推荐使用。pCLE 可能为识别局部复发提供一些有价值的贡献。
该方案在临床试验（ClinicalTrials.gov 标识符 NCT02284802）中进行了注册。
