Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Hindenburgdamm 30, 12203, Berlin, Germany.
Krankenhaus Holweide, Medizinische Klinik, Kliniken der Stadt Köln, 51058, Cologne, Germany.
Surg Endosc. 2018 Sep;32(9):3981-3988. doi: 10.1007/s00464-018-6141-0. Epub 2018 Mar 12.
The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™.
In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months.
Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001).
SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.
本研究旨在评估单操作胆管镜（SOC）联合SpyGlassDS™在诊断和治疗中的应用价值。
在 2015 年 11 月至 2017 年 1 月期间进行的一项回顾性多中心研究中，对参与中心的 SpyGlassDS™检查进行了分析。分析了 SOC 的适应证、活检的准确性、大胆管结石的处理以及并发症等情况。随访时间为 4 个月。
在 250 例检查中，有 206 例患者进行了评估。适应证包括胆管结石（n=132）、胆管狭窄（n=93）、结石合并狭窄（n=24）和胆管漏（n=1）。在 117 例疑似恶性肿瘤的病例中，99 例病变可分为良性（n=55）或恶性（n=44），提示该适应证肿瘤的灵敏度为 95.5%，特异性为 94.5%。SOC 引导下活检的灵敏度为 57.7%，特异性为 100%。在 107 例检查中，可视胆管结石并可完全取出，91.1%的患者需进行 3 次操作（范围 1-6 次）才能最终清除结石。在 75 例患者中进行了碎石治疗，71 例（95%）成功。45 例患者中有 4 例（8.9%）接受了胆囊切除术和外科胆管修正术作为最终治疗。250 例患者中有 33 例（13.2%）发生不良事件（AE），1 例（0.4%）发生严重不良事件（SAE）。围手术期应用抗生素后胆管炎发生率为 1%（n=102），未应用抗生素预防时胆管炎发生率为 12.8%（n=148）（p<0.001）。
SOC 联合 SpyGlassDS™ 已成为诊断不明原因胆管病变和治疗大胆管结石的新标准。SOC 引导下活检的诊断率很高，大多数情况下可明确诊断，应通过标准化活检方案加以提高。SOC 引导下的介入治疗允许通过 SOC 引导下的碎石术清除大的胆管结石。通过单次使用抗生素治疗，可显著降低 13.2%的并发症发生率。
