Calgary Registry for Advanced and Therapeutic Endoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic retrograde pancreatography (ERCP).
- Who it may be relevant to
- Registry conditions: Biliary Disease, Pancreatic Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Endoscopic retrograde pancreatography (ERCP)
Endoscopic procedure to access biliary and/or pancreatic structures
Primary outcome measures
- Rate of unplanned healthcare utilization [Time frame: 30 days]
Secondary outcome measures (4)
- Rate of post-ERCP pancreatitis [Time frame: 30 days]
- Rate of post-ERCP bleeding [Time frame: 30 days]
- Rate of post-ERCP cholangitis or sepsis [Time frame: 30 days]
- Technical success rates [Time frame: Immediate]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Canada · 1 center
- University of Calgary — Calgary
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. PMID 33146812
Identifiers
NCT: NCT04259580 · REB18-0410