Biliary Disease, Pancreatic Diseases
Conditions
Brief summary
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.
Interventions
PROCEDUREEndoscopic retrograde pancreatography (ERCP)
Endoscopic procedure to access biliary and/or pancreatic structures
Sponsors
University of Calgary
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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.
Exclusion criteria
-none other than inverses of above.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of unplanned healthcare utilization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-ERCP pancreatitis | 30 days | Typical abdominal pain with amylase/lipase 3 times normal or higher |
| Rate of post-ERCP bleeding | 30 days | Hematemesis and/or melena or hemoglobin drop 2 g or greater |
| Rate of post-ERCP cholangitis or sepsis | 30 days | Fever \> 38C for 24 hours or more with cholestasis, or positive blood cultures |
| Technical success rates | Immediate | — |
Countries
Canada
Contacts
CONTACTNauzer Forbes, MD, MSc
Outcome results
None listed