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A Partially Randomized Diagnostic Trial of OCT-EUS Integration: Enhancing Surgical Margin Delineation and Lymph Node
Yutao Wang1, Lu Zhao2, Jiahao Zhao1
1Northern Jiangsu People's Hospital Affiliated to Yangzhou University, Yangzhou University, Yangzhou, China.
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.
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