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Calgary Registry for Advanced and Therapeutic Endoscopy

NCT ID: NCT04259580

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Disease Pancreatic Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic retrograde pancreatography (ERCP)

Endoscopic procedure to access biliary and/or pancreatic structures

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Nauzer Forbes, MD, MSc

Role: CONTACT

Phone: 403-592-5089

Email: [email protected]

Facility Contacts

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Nauzer Forbes, MD, MSc

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33146812 (View on PubMed)

Other Identifiers

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REB18-0410

Identifier Type: -

Identifier Source: org_study_id