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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic retrograde pancreatography (ERCP) | Procedure | Endoscopic procedure to access biliary and/or pancreatic structures |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of post-ERCP pancreatitis | Typical abdominal pain with amylase/lipase 3 times normal or higher | 30 days |
| Rate of post-ERCP bleeding | Hematemesis and/or melena or hemoglobin drop 2 g or greater |
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Inclusion Criteria:
Exclusion Criteria:
-none other than inverses of above.
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Adult patients undergoing ERCP.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nauzer Forbes, MD, MSc | Contact | 403-592-5089 | nauzer.forbes@ucalgary.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33146812 | Derived | 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. |
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Future studies will utilize patient-specific data, which will be in a de-identified encrypted secure format whenever shared.
For 5 years after data collection is complete.
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| 30 days |
| Rate of post-ERCP cholangitis or sepsis | Fever > 38C for 24 hours or more with cholestasis, or positive blood cultures | 30 days |
| Technical success rates | Immediate |