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Recruiting

NCT Number: NCT04259580

Calgary Registry for Advanced and Therapeutic Endoscopy

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.

Recruiting

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Key information

Conditions

Biliary Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location status: Recruiting

Location contact

Nauzer Forbes, MD, MSc

CONTACT

[email protected]

403-592-5089

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic retrograde pancreatography (ERCP)

Procedure

Endoscopic procedure to access biliary and/or pancreatic structures

Primary outcomes

  1. Rate of unplanned healthcare utilization

    Time frame: 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 outcomes

  1. Rate of post-ERCP pancreatitis

    Time frame: 30 days

    Typical abdominal pain with amylase/lipase 3 times normal or higher

  2. Rate of post-ERCP bleeding

    Time frame: 30 days

    Hematemesis and/or melena or hemoglobin drop 2 g or greater

  3. Rate of post-ERCP cholangitis or sepsis

    Time frame: 30 days

    Fever > 38C for 24 hours or more with cholestasis, or positive blood cultures

  4. Technical success rates

    Time frame: Immediate

Study contacts

Contact information is provided by the study sponsor or research team.

Nauzer Forbes, MD, MSc

CONTACT

[email protected]

403-592-5089

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Acronym: CReATE

Important dates

Study start
2018
Primary completion
2029
Study completion
2030
First posted
Feb 6, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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