光学相干断层扫描-超声内镜整合的部分随机诊断试验：提高肿瘤切除术中手术切缘的界定及淋巴结清扫效果
A Partially Randomized Diagnostic Trial of OCT-EUS Integration: Enhancing Surgical Margin Delineation and Lymph Node Dissection in Oncological Resection.
作者信息
Wang Yutao, Zhao Lu, Zhao Jiahao, Wei Xuanyu, Wang Daorong, Liu Jun, Hu Linjie, Xu Bing, Ji Jun, Zhang Jiayi, Chen Chaowu, Tang Dong
机构信息
Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou University, Yangzhou, China.
The Yangzhou Clinical College of Xuzhou Medical University, Xuzhou Medical University, Yangzhou, China.
出版信息
Clin Med Insights Oncol. 2025 Sep 12;19:11795549251363829. doi: 10.1177/11795549251363829. eCollection 2025.
BACKGROUND
Accurate intraoperative navigation remains challenging in gastrointestinal tumor surgery. This study aims to explore the potential of optical coherence tomography (OCT) and endoscopic ultrasonography (EUS) in enhancing the accuracy of intraoperative navigation.
METHODS
This single-center diagnostic study was conducted at Northern Jiangsu People's Hospital from August to December 2024. This study is part of a prospective study, and more patients will be recruited in the future. The normal tissues, tumor tissues, vascular tissues, adipose tissues and lymph nodes of 12 patients with gastrointestinal tumors were collected for OCT and EUS scanning, and the image differences were compared. In addition, 43 lymph node specimens from 18 randomly selected patients were scanned by OCT and EUS, and pathological reports were used as the baseline. The results of OCT and EUS were compared retrospectively.
RESULTS
There are notable differences between OCT and EUS imaging. EUS can capture images of the entire tissue layer, making it more effective than OCT in assessing tumor invasion depth. Conversely, OCT serves as an "optical biopsy," providing higher precision in the early stages of lesions. Our further research indicates that the combined application of these modalities holds significant potential. In a double-blind evaluation of 43 lymph nodes from 18 randomly selected patients, OCT demonstrated a sensitivity of 81.25%, specificity of 88.89%, and a positive predictive value (PPV) of 81.25%. In comparison, EUS showed a sensitivity of 87.50%, specificity of 85.19%, and a PPV of 77.78%. The combined use of OCT and EUS achieved a sensitivity of 93.75%, specificity of 92.59%, and a PPV of 88.24%.
CONCLUSIONS
The combined use of OCT and EUS can enhance sensitivity and specificity, thereby improving the accuracy of intraoperative navigation.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (No. ChiCTR2400088875); Registered 28 August 2024, first patient enrolled 20 September 2024.
背景
在胃肠道肿瘤手术中，准确的术中导航仍然具有挑战性。本研究旨在探讨光学相干断层扫描（OCT）和内镜超声检查（EUS）在提高术中导航准确性方面的潜力。
方法
本单中心诊断性研究于2024年8月至12月在苏北人民医院进行。本研究是一项前瞻性研究的一部分，未来将招募更多患者。收集12例胃肠道肿瘤患者的正常组织、肿瘤组织、血管组织、脂肪组织和淋巴结进行OCT和EUS扫描，并比较图像差异。此外，对18例随机选择患者的43个淋巴结标本进行OCT和EUS扫描，以病理报告作为基线。对OCT和EUS的结果进行回顾性比较。
结果
OCT和EUS成像存在显著差异。EUS可以获取整个组织层的图像，在评估肿瘤浸润深度方面比OCT更有效。相反，OCT作为一种“光学活检”，在病变早期提供更高的精度。我们的进一步研究表明，这些方法的联合应用具有巨大潜力。在对18例随机选择患者的43个淋巴结进行的双盲评估中，OCT的敏感性为81.25%，特异性为88.89%，阳性预测值（PPV）为81.25%。相比之下，EUS的敏感性为87.50%，特异性为85.19%，PPV为77.78%。OCT和EUS联合使用的敏感性为93.75%，特异性为92.59%，PPV为88.24%。
结论
OCT和EUS联合使用可以提高敏感性和特异性，从而提高术中导航的准确性。
试验注册
中国临床试验注册中心（编号：ChiCTR2400088875）；2024年8月28日注册，首例患者于2024年9月20日入组。
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