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Abstract：
Background and study aims Digital single-operator cholangioscopy (DSOC) allows the diagnosis of biliary duct disorders and treatment for complicated stones. However, these technologies have limitations such as the size of the probe and working channel, excessive cost, and low image resolution. Recently, a novel DSOC system (eyeMAX, Micro-Tech, Nanjing, China) was developed to address these limitations. We aimed to evaluate the usefulness and safety of a novel 9F and 11F DSOC system in terms of neoplastic diagnostic accuracy based on visual examination, ability to evaluate tumor extension and to achieve complete biliary stone clearance, and procedure-related adverse events (AEs). Patients and methods Data from ≥ 18-year-old patients who underwent DSOC from July 2021 to April 2022 were retrospectively recovered and divided into a diagnostic and a therapeutic cohort. Results A total of 80 patients were included. In the diagnostic cohort (n = 49/80), neovascularity was identified in 26 of 49 patients (46.9%). Biopsy was performed in 65.3% patients with adequate tissue sample obtained in 96.8% of cases. Biopsy confirmed neoplasia in 23 of 32 cases. DSOC visual impression achieved 91.6% sensitivity and 87.5% specificity in diagnosing neoplasms. In the therapeutic cohort (n = 43/80), 26 of 43 patients required lithotripsy alone. Total stone removal was achieved in 71% patients in the first session. Neither early nor late AEs were documented in either the diagnostic or therapeutic cohort. Conclusions The novel DSOC device has excellent diagnostic accuracy in distinguishing neoplastic biliary lesions as well as therapeutic benefits in the context of total stone removal, with no documented AEs.
摘要：
背景和研究目的数字单操作员胆道镜检查（DSOC）可以诊断胆管疾病和治疗复杂的结石。然而,这些技术有局限性，如探头和工作通道的大小，成本过高,图像分辨率低。最近,一种新颖的DSOC系统(eyeMAX，Micro-Tech,南京,中国)的发展是为了解决这些限制。我们旨在基于视觉检查评估新型9F和11FDSOC系统在肿瘤诊断准确性方面的有用性和安全性。评估肿瘤扩展和实现胆管结石完全清除的能力，和与程序相关的不良事件（AE）。患者和方法对2021年7月至2022年4月接受DSOC的≥18岁患者的数据进行回顾性恢复，并分为诊断和治疗队列。结果共纳入80例患者。在诊断队列中（n=49/80），49例患者中有26例(46.9%)发现新生血管.在65.3％的患者中进行了活检，在96.8％的病例中获得了足够的组织样本。32例中有23例活检证实为肿瘤。DSOC视觉印象在诊断肿瘤方面达到91.6％的敏感性和87.5％的特异性。在治疗队列中（n=43/80），43例患者中有26例需要单独碎石术。在第一届会议中，71％的患者实现了全部结石清除。在诊断或治疗队列中均未记录早期或晚期AE。结论新型DSOC装置在区分胆道肿瘤病变方面具有出色的诊断准确性，并且在完全取石的情况下具有治疗益处。没有记录的AE。
