The Percutaneous Cholangiopancreatoscopy Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 679
- 试验地点
- 1
- 主要终点
- Tube free survival
研究概览
简要总结
The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Male or female adults
- •18 years of age and older
- •Patients undergoing clinically indicated percutaneous cholangiopancreatoscopy procedure at the Johns Hopkins Hospital or one of the registry sites.
- •Willing and able to understand and sign a written informed consent document for the prospective component of the study.
排除标准
- •Pregnant women
- •Children (< 18 years of age)
结局指标
主要结局
Tube free survival
时间窗: Up to 3 years
Tube free survival will be calculated by estimating the number of patients who can undergo removal of the biliary/ cholecystostomy tube after the PCPS procedure until their last IR clinical follow-up or death.
次要结局
- Complication rate(1 month)
- Procedural success(At the time of the procedure)
- Technical success(At the time of the procedure)
- Clinical success(At the time of the procedure)
- Complication rate(At the time of the procedure)