经口胆道镜EyeMax胆胰成像系统对胆管良恶性狭窄的诊断及治疗价值的研究
Study on the Value of Oral Choledochoscopy EyeMax Biliary and Pancreatic Imaging System in Diagnosis and Treatment of Benign and Malignant Bile Duct Stenosis

目的：探讨新型国产直接经口胆道镜EyeMax胆胰成像系统在胆管良恶性狭窄的诊断及治疗方面的价值。方法：回顾性分析2021年12月至2023年12月期间，在烟台毓璜顶医院采用直接经口胆道镜EyeMax胆胰成像系统的55例胆管狭窄患者的临床资料，观察胆管狭窄的影像特点及类型，以病理和长期随访结果为金标准，评估EyeMax视觉印象和镜下病理的敏感度、特异度、阳性预测值、阴性预测值、准确率，并与磁共振胰胆管成像(MRCP)进行上述五方面的对比，并评估EyeMax镜下行胰胆管支架置入术的成功率及安全性。结果：根据影像学检查、实验室检查、病理诊断及随访情况综合判断，在55例患者中，有34例患者最终诊断为胆管良性狭窄，21例患者最终诊断为胆管恶性狭窄。EyeMax视觉印象的诊断灵敏度为100% (21/21)，特异度为94.1% (32/34)，阳性预测值为91.3% (21/23)，阴性预测值为100% (32/32)，准确率为96.4% (53/55)。EyeMax病理活检诊断胆管狭窄良恶性的灵敏度为13/14 (92.9%)，特异度为100% (7/7)，阳性预测值为100% (13/13)，阴性预测值为7/8 (87.5%)，准确率为95.2% (20/21)。共有33例胆管狭窄患者行EyeMax镜下胰胆管支架置入术，操作成功率为100% (33/33)，术后共有4例患者出现并发症，并发症发生率为12.1% (4/33)，4例患者中有3例患者出现高淀粉酶血症，1例患者出现轻度胰腺炎，经抑酸、抑酶、抗感染等保守治疗后均在3天内基本恢复正常，未出现消化道出血、穿孔等严重并发症。结论：EyeMax胆胰成像系统能够对多数胆管狭窄进行相对高准确率的良恶性的鉴别，且能相对安全、高效地完成胰胆管支架置入术从而解除或部分解除胆管狭窄。
Objective: To discuss the value of EyeMax cholecancreatic imaging system in the diagnosis and treatment of benign and malignant bile duct stenosis. Methods: The clinical data of 55 patients with biliary stenosis who received EyeMax biliary and pancreatic imaging system with direct transoral choledochoscope in Yuhuangding Hospital, Yantai from December 2021 to December 2023 were retrospectively analyzed to observe the imaging characteristics and types of biliary stenosis, with pathological and long-term follow-up results as the gold standard. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EyeMax visual impression and endoscopic pathology were evaluated, and the above five aspects were compared with magnetic resonance cholangiopancreatography (MRCP), and the success rate and safety of bile duct stenting under EyeMax microscope were evaluated. Results: According to the comprehensive judgment of imaging examination, laboratory examination, pathological diagnosis and follow-up, 34 of the 55 patients were finally diagnosed with benign bile duct stenosis, and 21 patients were finally diagnosed with malignant bile duct stenosis. The diagnostic sensitivity of EyeMax visual impression was 100% (21/21), the specificity was 94.1% (32/34), the positive predictive value was 91.3% (21/23), the negative predictive value was 100% (32/32), and the accuracy was 96.4% (53/55). The sensitivity of EyeMax pathological biopsy for the diagnosis of benign and malignant biliary stenosis was 13/14 (92.9%), the specificity was 100% (7/7), the positive predictive value was