University of Colorado Health Sciences Center, Denver, CO, USA.
Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
The feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported.
To confirm the utility of SOC in more widespread clinical use.
Prospective clinical cohort study.
Fifteen endoscopy referral centers in the United States and Europe.
Two hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy.
SOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy.
Procedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal.
The overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy.
The study was observational in design with no control group.
Evaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.
先前已有研究报道过单人操作胆道镜（SOC）在胆道诊断和治疗操作中的可行性。
确认 SOC 在更广泛的临床应用中的实用性。
前瞻性临床队列研究。
美国和欧洲的 15 个内镜转诊中心。
297 例需要评估胆管疾病或胆道结石治疗的患者。
SOC 检查，以及有指征时进行 SOC 引导的结石治疗或活检钳取活检。
定义为（1）有能力观察目标病变，如果有必要，采集足够进行组织学评估的活检标本，或（2）观察到胆道结石并开始进行碎裂和取出的程序成功率。
总体手术成功率为 89%（95%CI，84%-92%）。140 例行活检的患者中，有 88%获得了足够用于组织学检查的组织。SOC 视觉印象诊断恶性肿瘤的总体敏感性为 78%，SOC 引导活检的敏感性为 49%。对于原发性胆管恶性肿瘤，敏感性更高（分别为 84%和 66%）。SOC 诊断程序改变了 64%的患者的临床管理。66 例结石患者中，92%的患者手术成功，且在研究 SOC 过程中，71%的患者完全清除结石。诊断性 SOC 的严重程序相关不良事件发生率为 7.5%，SOC 引导的结石治疗为 6.1%。
该研究为观察性设计，没有对照组。
使用 SOC 系统可以安全地对胆管疾病和胆道结石治疗进行评估，成功率高。
