Calgary Registry for Advanced and Therapeutic Endoscopy

NCT04259580 | Recruiting FDA Device

• 1 other identifier: REB18-0410
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Disease; Pancreatic Diseases

Outcome Measures

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.

  30 days

Secondary Outcomes (4)

• Rate of post-ERCP pancreatitis

  30 days

• Rate of post-ERCP bleeding

  30 days

• Rate of post-ERCP cholangitis or sepsis

  30 days

• Technical success rates

  Immediate

Interventions

Endoscopic retrograde pancreatography (ERCP) PROCEDURE

Endoscopic procedure to access biliary and/or pancreatic structures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing ERCP.

You may qualify if:

• 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.

You may not qualify if:

• none other than inverses of above.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33146812 DERIVED

MeSH Terms

Conditions

Gallbladder Diseases; Pancreatic Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Nauzer Forbes, MD, MSc

CONTACT

403-592-5089; nauzer.forbes@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 1, 2018
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 5 years after data collection is complete.

Locations

CA (1)