BACKGROUND AND AIMS Accurately diagnosing indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy sampling under direct cholangioscopic vision might be superior to standard ERCP techniques such as brushing or biopsy sampling. Our aim was to investigate whether digital single-operator cholangioscopy (DSOC) compared with standard ERCP workup improves the diagnostic yield in patients with indeterminate biliary strictures. METHODS Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (control arm [CA]) or DSOC visualization and DSOC-guided biopsy sampling (study arm [SA]). This was a prospective, international, multicenter trial with a procedure-blinded pathologist. RESULTS The first sample sensitivity of DSOC-guided biopsy samples was significantly higher than ERCP-guided brushing (SA 68.2% vs CA 21.4%, P < .01). The sensitivity of visualization (SA 95.5% vs CA 66.7%, P = .02) and overall accuracy (SA 87.1% vs CA 65.5%, P = .05) were significantly higher in the SA compared with the CA, whereas specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms. CONCLUSIONS DSOC-guided biopsy sampling was shown to be safe and effective with a higher sensitivity compared with standard ERCP techniques in the visual and histopathologic diagnosis of indeterminate biliary strictures. (Clinical trial registration number: NCT03140007.).

中文翻译：

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对于不确定的胆道狭窄，数字单手术经口胆管镜引导下活检取样与ERCP引导刷牙：前瞻性，随机，多中心试验（视频）。

背景和目的准确诊断不确定的胆道狭窄是具有挑战性的，但对患者的预后和进一步治疗很重要。直接胆管镜下的活检取样可能优于标准的ERCP技术，例如刷牙或活检取样。我们的目的是研究将数字单手术胆道镜检查（DSOC）与标准ERCP检查相比较是否能提高不确定的胆道狭窄患者的诊断率。方法将基于MRCP的不确定性胆管狭窄患者随机分为标准ERCP可视化，包括组织刷（对照组[CA]）或DSOC可视化以及DSOC引导下的活检样本（研究组[SA]）。这是一个对程序盲的病理学家进行的前瞻性国际多中心试验。结果DSOC引导的活检样本的首次样本敏感性显着高于ERCP引导的刷洗（SA 68.2％vs CA 21.4％，P <.01）。与CA相比，SA的可视化灵敏度（SA 95.5％vs CA 66.7％，P = .02）和总体准确性（SA 87.1％vs CA 65.5％，P = .05）显着高于CA，而特异性为阳性预测值和阴性预测值无显着差异。不良事件的发生率均低。结论在不确定的胆道狭窄的视觉和组织病理学诊断中，与标准的ERCP技术相比，DSOC引导的活检样本被证明是安全有效的，并且具有更高的灵敏度。（临床试验注册号：NCT03140007。）。2％vs CA 21.4％，P <0.01）。与CA相比，SA的可视化灵敏度（SA 95.5％vs CA 66.7％，P = .02）和总体准确性（SA 87.1％vs CA 65.5％，P = .05）显着高于CA，而特异性为阳性预测值和阴性预测值无显着差异。不良事件的发生率均低。结论在不确定的胆道狭窄的视觉和组织病理学诊断中，与标准的ERCP技术相比，DSOC引导的活检样本被证明是安全有效的，并且具有更高的灵敏度。（临床试验注册号：NCT03140007。）。2％vs CA 21.4％，P <0.01）。与CA相比，SA的可视化灵敏度（SA 95.5％vs CA 66.7％，P = .02）和总体准确性（SA 87.1％vs CA 65.5％，P = .05）显着高于CA，而特异性为阳性预测值和阴性预测值无显着差异。不良事件的发生率均低。结论在不确定的胆道狭窄的视觉和组织病理学诊断中，与标准的ERCP技术相比，DSOC引导的活检样本被证明是安全有效的，并且具有更高的灵敏度。（临床试验注册号：NCT03140007。）。阳性预测值和阴性预测值无显着差异。不良事件的发生率均低。结论在不确定的胆道狭窄的视觉和组织病理学诊断中，与标准的ERCP技术相比，DSOC引导的活检样本被证明是安全有效的，并且具有更高的灵敏度。（临床试验注册号：NCT03140007。）。阳性预测值和阴性预测值无显着差异。不良事件的发生率均低。结论在不确定的胆道狭窄的视觉和组织病理学诊断中，与标准的ERCP技术相比，DSOC引导的活检样本被证明是安全有效的，并且具有更高的灵敏度。（临床试验注册号：NCT03140007。）。