Per-Oral Cholangioscopy in Liver Transplantation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- Impact of Per-Oral Cholangioscopy on Patient Management
研究概览
简要总结
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.
详细描述
The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.
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
- •Liver transplantation at least 1 month prior to POCS procedure
- •Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
- •Prior cross sectional imaging (MRI and/or US and/or CT)
- •Suspicion of anastomotic biliary stricture(s)
- •Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
- •Willing and able to provide a written informed consent to participate in the study
- •Willing and able to comply with study procedures and follow-up schedule
排除标准
- •Contraindication for an ERCP per local standard of practice
- •Deemed contraindicated for POCS per local standard of practice
- •Prior biliary treatment of biliary anastomotic stricture
- •< 18 years old
- •Documented life expectancy of less than 12 months.
结局指标
主要结局
Impact of Per-Oral Cholangioscopy on Patient Management
时间窗: 12 Months
To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.
次要结局
- Technical Success(12 Months)
- Serious Adverse Events(12 Months)
- Number of biliary re-interventions(12 Months)
- Patient Management(3 and 12 Months)
- Relationship between endoscopic findings on POCS visualization(12 Months)
- Evaluation(12 Months)