Division of Gastroenterology and Digestive Endoscopy, Department of Gastroenterology, IRCCS - Humanitas Research Hospital, Via Manzoni 56, Rozzano, Milan 20089, Italy.
Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Centre for Endoscopic research Therapeutics and training (CERTT), Roma, Italy.
Dig Liver Dis. 2022 Sep;54(9):1243-1249. doi: 10.1016/j.dld.2022.04.019. Epub 2022 May 18.
Digital single-operator cholangioscopy (D-SOC) is an endoscopic procedure that is increasingly used for the management of bilio-pancreatic diseases. We aimed to investigate the efficacy and safety of D-SOC for diagnostic and therapeutic indications.
This is a multicenter, prospective study(January 2016-June 2019) across eighteen tertiary centers. The primary outcome was procedural success of D-SOC. Secondary outcomes were: D-SOC visual assessment and diagnostic yield of SpyBite biopsy in cases of biliary strictures, stone clearance rate in cases of difficult biliary stones, rate of adverse events(AEs) for all indications.
D-SOC was performed in 369 patients (201(54,5%) diagnostic and 168(45,5%)therapeutic). Overall, procedural success rate was achieved in 360(97,6%) patients. The sensitivity, specificity, PPV, NPV and accuracy in biliary strictures were: 88,5%, 77,3%, 83,3%, 84,1% and 83,6% for D-SOC visual impression; 80,2%, 92,6%, 95,1%, 72,5% and 84,7% for the SpyBite biopsy, respectively. For difficult biliary stones, complete duct clearance was obtained in 92,1% patients (82,1% in a single session). Overall, AEs occurred in 37(10%) cases.The grade of AEs was mild or moderate for all cases, except one which was fatal.
D-SOC is effective for diagnostic and therapeutic indications.Most of the AEs were minor and managed conservatively, even though a fatal event has happened that is not negligible and should be considered before using D-SOC.
数字单操作胆管镜检查（D-SOC）是一种越来越多地用于治疗胆胰疾病的内镜检查程序。我们旨在研究 D-SOC 在诊断和治疗适应证中的疗效和安全性。
这是一项多中心、前瞻性研究（2016 年 1 月至 2019 年 6 月），涉及 18 个三级中心。主要结局是 D-SOC 的程序成功。次要结局是：D-SOC 在胆道狭窄病例中的视觉评估和 SpyBite 活检的诊断率、在困难性胆道结石病例中的结石清除率、所有适应证的不良事件（AE）发生率。
对 369 例患者进行了 D-SOC（201 例（54.5%）为诊断性，168 例（45.5%）为治疗性）。总体而言，360 例（97.6%）患者实现了程序成功。D-SOC 视觉印象在胆道狭窄中的灵敏度、特异性、PPV、NPV 和准确性分别为 88.5%、77.3%、83.3%、84.1%和 83.6%；SpyBite 活检分别为 80.2%、92.6%、95.1%、72.5%和 84.7%。对于困难性胆道结石，92.1%的患者（82.1%在单次治疗中）获得了完全胆管清除。总体而言，37 例（10%）患者发生了 AE。所有病例的 AE 程度均为轻度或中度，除一例为致命性。
D-SOC 对诊断和治疗适应证有效。大多数 AE 为轻微且保守治疗，尽管发生了一起不可忽视的致命事件，在使用 D-SOC 之前应考虑到这一点。
