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CReATE: Calgary Registry for Advanced and Therapeutic Endoscopy

Sponsor
University of Calgary (Other)
Overall Status
Recruiting
CT.gov ID
NCT04259580
Collaborator
(none)
6,000
Enrollment
1
Location
73
Anticipated Duration (Months)
82.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Endoscopic retrograde pancreatography (ERCP)

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
6000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Calgary Registry for Advanced and Therapeutic Endoscopy
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Rate of post-ERCP pancreatitis [30 days]

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

  2. Rate of post-ERCP bleeding [30 days]

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

  3. Rate of post-ERCP cholangitis or sepsis [30 days]

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

  4. Technical success rates [Immediate]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Calgary Calgary Alberta Canada T2N 4Z6

Sponsors and Collaborators

  • University of Calgary

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT04259580
Other Study ID Numbers:
  • REB18-0410
First Posted:
Feb 6, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Pancreatic Diseases
Gallbladder Diseases

Study Results

No Results Posted as of Apr 27, 2021