Department of Internal Medicine I, University Hospital Regensburg, Regensburg, Germany,
Department of Internal Medicine I, University Hospital Regensburg, Regensburg, Germany.
Digestion. 2021;102(5):776-782. doi: 10.1159/000513713. Epub 2021 Feb 25.
BACKGROUND/AIMS: Digital single-operator cholangioscopy (dSOC) has revolutionized bile duct visualization. Interventions like electrohydraulic or laser lithotripsy, inspection of suspicious areas, and targeted biopsies have become possible quick and easy. One main indication for dSOC remains the evaluation of indeterminate biliary strictures.
We analyzed 180 consecutive dSOCs procedures performed in a high-volume tertiary center to evaluate sensitivity, specificity as well as positive and negative predictive values (PPV and NPV) for indeterminate strictures. Furthermore, technical success and complications were analyzed.
In 92-97%, the region of interest was reached and successfully visualized. In 83-100%, targeted biopsies were obtained from the suspicious area. Only the distal bile duct was less successful with only 84 and 62%, respectively. In general, dSOC procedures were safe. Cholangitis was the main complication. Regarding the diagnostic accuracy of dSOC of indeterminate biliary strictures, we found a sensitivity of 0.87 and specificity of 0.88, over all. Within the whole cohort, the investigators' assessment directly after dSOC had a PPV of 0.63 and a NPV of 0.97. In patients with biliary lesions or stenosis suspicious for malignancy, the dSOC-based visual diagnosis revealed a very high diagnostic accuracy with sensitivity and specificity of 1.0 (95% CI 0.86-1.0) and 0.76 (95% CI 0.56-0.9) with a PPV of 0.77 (95% CI 0.59-0.9) and a high NPV of 1.0 (95% CI 0.85-1.0).
Our study demonstrates that dSOC has a high diagnostic accuracy as well as a favorable safety profile. Therefore, dSOC should be discussed as standard of care during endoscopic retrograde cholangiography for indeterminate biliary lesions.
背景/目的：数字单操作员胆管镜检查（dSOC）彻底改变了胆管可视化。现在可以快速、轻松地进行电液压或激光碎石、可疑区域检查和靶向活检等干预措施。dSOC 的一个主要适应证仍然是评估不确定的胆管狭窄。
我们分析了在高容量三级中心进行的 180 例连续 dSOC 手术，以评估不确定狭窄的敏感性、特异性以及阳性和阴性预测值（PPV 和 NPV）。此外，还分析了技术成功率和并发症。
在 92-97%的情况下，到达并成功可视化了目标区域。在 83-100%的情况下，从可疑区域获得了靶向活检。只有远端胆管的成功率较低，分别为 84%和 62%。总的来说，dSOC 手术是安全的。胆管炎是主要并发症。关于不确定胆管狭窄的 dSOC 诊断准确性，我们发现总敏感性为 0.87，特异性为 0.88。在整个队列中，研究者在 dSOC 后直接评估的 PPV 为 0.63，NPV 为 0.97。在可疑有胆管病变或狭窄恶性肿瘤的患者中，基于 dSOC 的视觉诊断具有非常高的诊断准确性，敏感性和特异性分别为 1.0（95%CI 0.86-1.0）和 0.76（95%CI 0.56-0.9），PPV 为 0.77（95%CI 0.59-0.9），NPV 为 1.0（95%CI 0.85-1.0）。
我们的研究表明，dSOC 具有较高的诊断准确性和良好的安全性。因此，在经内镜逆行胰胆管造影术（ERCP）检查不确定的胆管病变时，应将 dSOC 作为标准治疗方法进行讨论。
