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.
Study Type
OBSERVATIONAL
Enrollment
6,000
Endoscopic procedure to access biliary and/or pancreatic structures
University of Calgary
Calgary, Alberta, Canada
RECRUITINGRate of unplanned healthcare utilization
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.
Time frame: 30 days
Rate of post-ERCP pancreatitis
Typical abdominal pain with amylase/lipase 3 times normal or higher
Time frame: 30 days
Rate of post-ERCP bleeding
Hematemesis and/or melena or hemoglobin drop 2 g or greater
Time frame: 30 days
Rate of post-ERCP cholangitis or sepsis
Fever \> 38C for 24 hours or more with cholestasis, or positive blood cultures
Time frame: 30 days
Technical success rates
Time frame: Immediate
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