Calgary Registry for Advanced and Therapeutic Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Rate of unplanned healthcare utilization
研究概览
简要总结
The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multi-centre registry. The study population consists of consecutive adult ERCP patients from September 2018 to August 2022. Informed consent is acquired for each patient. All relevant pre-procedural, procedural, peri-procedural and post-procedural data are captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes are ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. This registry also serves as a secure data collection platform for several currently recruiting prospective studies and randomized trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •any standard indication for ERCP, in the absence of standard contraindications;
- •age 18 years or over;
- •ability and willingness to give informed consent to be included in the registry and/or to involvement in one (or more) prospective sub-studies, or accompaniment by a surrogate who is willing and able to provide consent.
排除标准
- •none other than inverses of above.
结局指标
主要结局
Rate of unplanned healthcare utilization
时间窗: 30 days
Composite outcome of post-ERCP pancreatitis, bleeding, cholangitis or sepsis, or any other adverse event deemed related to the index procedure, or emergency department presentation or inpatient admission within 30 days deemed related to the index procedure.
次要结局
- Rate of post-ERCP bleeding(30 days)
- Rate of post-ERCP pancreatitis(30 days)
- Rate of post-ERCP cholangitis or sepsis(30 days)
- Technical success rates(Immediate)