Incidence and Predictors of Bleeding During and Following ERCP

NCT05929404 | Completed

• 1 other identifier: REB 23-0438
• Study Type: observational
• Target: 5,872
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of bleeding during ERCP and following ERCP has been estimated using retrospective sources, but granular predictors of bleeding remain unknown, including the use of direct-acting anticoagulants and discontinuation and resumption patterns surrounding their use. In this study, we will aim to assess the incidence and predictors of intra-procedural bleeding during ERCP, and clinically significant post-procedural bleeding following ERCP.

Conditions

Bleeding UGI (During or Post-ERCP)

Keywords

Post-ERCP Bleeding; Intraprocedural Bleeding

Outcome Measures

Primary Outcomes (1)

• Clinically significant post-ERCP bleeding

  Clinically significant post-ERCP bleeding will be defined using established definitions (Cotton et al. Gastrointest Endoscopy 2010; Forbes et al. Gut 2022).

  30 days

Study Arms (2)

Patients on antithrombotic medications

Participants undergoing ERCP procedure taking antithrombotic medications (including antiplatelet and/or anticoagulant medications) at baseline.

Non-antithrombotic users

Participants undergoing ERCP procedure not taking antithrombotic medications (including antiplatelet and/or anticoagulant medications) at baseline.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to a hospital-based endoscopy unit for consideration of ERCP.

You may qualify if:

• Subject referred for ERCP, regardless of indication;
• Subject age 18 years or older;
• Subject able to give informed consent to involvement be included.

You may not qualify if:

• Subject has a standard contraindication to ERCP;
• Subject or surrogate unable or unwilling to provide informed consent;
• Subject age \< 18 years.

Sponsors & Collaborators

• University of Calgary: lead
• McGill University: collaborator
• University of Ottawa: collaborator
• Queen's University: collaborator
• Island Health, Victoria, BC: collaborator
• University of Toronto: collaborator
• Radboud University Medical Center: collaborator
• Halton Healthcare: collaborator

Study Sites (1)

Peter Lougheed Center

Calgary, Alberta, Canada

Location

Related Publications (1)

• Bishay K, Ruan Y, Barkun AN, Chen YI, Singh A, Hookey L, Arya N, Calo NC, Grover SC, Siersema PD, Thosani N, Darvish-Kazem S, Siegal D, Bass S, Cole M, Lei Y, Li S, Mohamed R, Turbide C, Chau M, Howarth M, Cartwright S, Koury HF, Nashad T, Meng ZW, Tepox-Padron A, Kayal A, Gonzalez-Moreno E, Brenner DR, Smith ZL, Keswani RN, Elmunzer BJ, Wani S, Bridges RJ, Hilsden RJ, Heitman SJ, Forbes N. Incidence, Predictors, and Outcomes of Clinically Significant Post-Endoscopic Retrograde Cholangiopancreatography Bleeding: A Contemporary Multicenter Study. Am J Gastroenterol. 2024 Nov 1;119(11):2317-2325. doi: 10.14309/ajg.0000000000002946. Epub 2024 Jul 5.

  PMID: 39495582 DERIVED

Study Officials

• Nauzer Forbes, MD MSc

  Peter Lougheed Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: July 3, 2023
• Study Start: September 1, 2018
• Primary Completion: August 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

CA (1)