Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE)

April 26, 2021 updated by: University of Calgary
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing ERCP.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-ERCP pancreatitis
Time Frame: 30 days
Typical abdominal pain with amylase/lipase 3 times normal or higher
30 days
Rate of post-ERCP bleeding
Time Frame: 30 days
Hematemesis and/or melena or hemoglobin drop 2 g or greater
30 days
Rate of post-ERCP cholangitis or sepsis
Time Frame: 30 days
Fever > 38C for 24 hours or more with cholestasis, or positive blood cultures
30 days
Technical success rates
Time Frame: Immediate
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB18-0410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Future studies will utilize patient-specific data, which will be in a de-identified encrypted secure format whenever shared.

IPD Sharing Time Frame

For 5 years after data collection is complete.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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