ClinicalTrials.gg
RecruitingNCT04259580CReATEUpdated Apr 29, 2026

Calgary Registry for Advanced and Therapeutic Endoscopy

An observational study in Biliary Disease and Pancreatic Diseases, sponsored by University of Calgary. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University of Calgary · Observational

From the registry’s dates

  • Started Sep 2018; still recruiting 8 years 2 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
6,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Biliary Disease
  • Pancreatic Diseases
03

In context

Gallbladder Diseases

92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 220 across 29 observational studies indexed under Gallbladder Diseases.

Browse Gallbladder Diseases studies →

Lead sponsor

University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients undergoing ERCP.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • any standard indication for ERCP, in the absence of standard ;
  • age 18 years or over;
  • ability and willingness to give 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

Exclusion Criteria:

-none other than inverses of above.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
6,000 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Interventions

  • ProcedureEndoscopic retrograde pancreatography (ERCP)

    Endoscopic procedure to access biliary and/or pancreatic structures

06

What researchers measure

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 days

Secondary outcomes

  1. Rate of post-ERCP pancreatitis

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

    Time frame: 30 days

  2. Rate of post-ERCP bleeding

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

    Time frame: 30 days

  3. Rate of post-ERCP cholangitis or sepsis

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

    Time frame: 30 days

  4. Technical success rates

    Time frame: Immediate

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Mohamed R, Lethebe BC, Gonzalez-Moreno E, Kayal A, Bass S, Cole M, Turbide C, Chau M, Koury HF, Brenner DR, Hilsden RJ, Elmunzer BJ, Keswani RN, Wani S, Heitman SJ, Forbes N. Morphology of the major papilla predicts ERCP procedural outcomes and adverse events. Surg Endosc. 2021 Dec;35(12):6455-6465. doi: 10.1007/s00464-020-08136-9. Epub 2020 Nov 4. PubMed 33146812 ↗

Individual participant data

Plan to share: Yes — Future studies will utilize patient-specific data, which will be in a de-identified encrypted secure format whenever shared.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: For 5 years after data collection is complete.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04259580
Responsible party
Sponsor
First posted
Feb 6, 2020
Start date
Sep 1, 2018
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 29, 2026

Study contacts

Nauzer Forbes, MD, MSc
Contact
nauzer.forbes@ucalgary.ca
403-592-5089

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion