Cholangioscopy in Primary Sclerosing Cholangitis (PSC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- POCS-guided Biopsy for Early Detection of Cholangiocarcinoma
研究概览
简要总结
To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).
详细描述
The primary objective of this study is to demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard ERCP with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of PSC
- •Clinical indication for ERCP per local standard of practice, such as suspicion of potential malignancy based on worsening cholestatic values or clinical presentation (such as itching, cholangitis) or new biliary stricture on trans-abdominal imaging (MRI/MRCP, US or CT) or suspicious cytology
- •Diameter of bile ducts deemed sufficient to accommodate the cholangioscopy system based on imaging performed prior to scheduled ERCP
- •Written informed consent from patient to participate in the study, including compliance with study procedures.
排除标准
- •Contraindication for an ERCP or POCS
- •History of liver transplantation
- •Mass/metastasis extrinsic to the bile duct identifiable on diagnostic imaging
- •History of iatrogenic bile duct trauma, including biliary surgery within 6 months of enrollment
- •INR > 1.5 or platelets count < 50,000
- •Age < 18 years
- •Pregnant women or women trying to become pregnant
结局指标
主要结局
POCS-guided Biopsy for Early Detection of Cholangiocarcinoma
时间窗: 12 months
Diagnostic accuracy for POCS-guided Biopsy for cholangiocarcinoma evaluated on pathology at 12 months after initial POCS procedure.
Diagnostic Accuracy of POCS visualization for Early Detection of Cholangiocarcinoma
时间窗: 12 months
Diagnostic accuracy of POCS visualization for cholangiocarcinoma evaluated clinically at 12 months after initial POCS procedure by clinical presentation.
次要结局
- Rate of Adverse Events(From index through study completion, an average of one year)
- Correspondence of Biopsies(From index through study completion, an average of one year)
- Technical Success - Ability to advance the scope.(Baseline)
- Proportion of patients identified for repeat procedure.(During index procedure)