Calgary Registry for Advanced and Therapeutic Endoscopy

Recruiting

• Conditions: Biliary Disease; Pancreatic Diseases

• Registration Number: NCT04259580
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

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.

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Exclusion Criteria

-none other than inverses of above.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of post-ERCP bleeding	30 days	Hematemesis and/or melena or hemoglobin drop 2 g or greater
Rate of post-ERCP pancreatitis	30 days	Typical abdominal pain with amylase/lipase 3 times normal or higher
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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada