Calgary Registry for Advanced and Therapeutic Endoscopy

Pancreatic Diseases Clinical Trial

— CReATE  

Official title:

Calgary Registry for Advanced and Therapeutic Endoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04259580
• Other study ID #: REB18-0410
• Status: Recruiting
• Start date: September 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: Nauzer Forbes, MD, MSc
• Phone: 403-592-5089
• Email: nauzer.forbes[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Disease
• Gallbladder Diseases
• Pancreatic Diseases

Intervention

Procedure:
• Endoscopic retrograde pancreatography (ERCP)
Endoscopic procedure to access biliary and/or pancreatic structures

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of post-ERCP pancreatitis	Typical abdominal pain with amylase/lipase 3 times normal or higher	30 days
Secondary	Rate of post-ERCP bleeding	Hematemesis and/or melena or hemoglobin drop 2 g or greater	30 days
Secondary	Rate of post-ERCP cholangitis or sepsis	Fever > 38C for 24 hours or more with cholestasis, or positive blood cultures	30 days
Secondary	Technical success rates		Immediate