Calgary Registry for Advanced and Therapeutic Endoscopy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Calgary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Adult patients undergoing ERCP.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Endoscopic retrograde pancreatography (ERCP)
Procedure/SurgeryEndoscopic procedure to access biliary and/or pancreatic structures
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Rate 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 daysSecondary outcomes
1
Rate of post-ERCP pancreatitis
Typical abdominal pain with amylase/lipase 3 times normal or higher
Time frame
30 days2
Rate of post-ERCP bleeding
Hematemesis and/or melena or hemoglobin drop 2 g or greater
Time frame
30 days3
Rate of post-ERCP cholangitis or sepsis
Fever \> 38C for 24 hours or more with cholestasis, or positive blood cultures
Time frame
30 days4
Technical success rates
Time frame
ImmediateSponsors and contacts
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Source ClinicalTrials.gov