Incidence and Predictors of Bleeding During and Following ERCP

NCT ID: NCT05929404

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5872 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-11-30

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.

Detailed Description

While very effective, endoscopic retrograde cholangiopancreatography (ERCP) is widely known to have the highest adverse event (AE) profile among all commonly performed endoscopic procedures, with a collective AE rate of >10%. Common AEs include post-ERCP pancreatitis, bleeding, cholangitis, cholecystitis, perforation, and cardiopulmonary events. 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.

It is of critical priority to patients, practitioners, and health administrators to investigate factors associated with all AEs and unplanned healthcare encounters (UHEs) following ERCP, especially given that most ERCPs are performed on an outpatient basis. The per-admission costs of post-ERCP UHEs are substantial. Thus, researchers must prioritize the study of ERCP outcomes, striving to both identify and modify factors leading to AEs and UHEs.

(2) Research Question and Objectives 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.

(3) Methods Design: This is a multicenter prospective cohort study. The primary exposure of interest will be patient use of antithrombotic medications including antiplatelet agents and/or anticoagulant agents. In addition to these variables, other parameters we will assess include: the presence and timing of pharmacologic pancreatitis prophylaxis, extent and timing of trainee involvement, the number and timing of common bile duct (CBD) cannulation attempts, the depth, timing, trajectory and number of pancreatic duct (PD) cannulation(s), the presence and extent of PD opacification, the size(s) of sphincterotomy and/or sphincteroplasty, intra-procedural pathology, and the composition, caliber and length of any PD or CBD stent(s).

Outcomes: The primary outcomes will be clinically significant post-ERCP bleeding (CSPEB), using established definitions, and intra-procedural bleeding, defined as bleeding requiring endoscopic management during ERCP. Secondary outcomes (defined a priori) will include bleeding severity, overall and specific AEs (pancreatitis, cholangitis, cardio-pulmonary events), cannulation time and success rate, as well as overall procedure time and success rate.

Sample Size and Power: Using anticipated CSPEB rates of 2.0% for non-anticoagulant users and 5.0% for anticoagulant users, a minimum of 588 patients in each arm will be required to demonstrate this difference with 80% power and alpha of 0.05.

Statistical Analysis: Variables will be compared using Student's t-test for measured variables and chi-squared test for categorical variables. P values < 0.05 will be considered significant. We will use multivariable logistic regression to assess associations between risk factors and having bleeding versus not having bleeding. Clinically relevant subgroup analyses will also be performed by relevant patient-, endoscopist-, and procedure-related characteristics. Odds ratios per outcome will be reported with 95% CIs.

Conditions

Bleeding UGI (During or Post-ERCP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients on antithrombotic medications

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

No interventions assigned to this group

Non-antithrombotic users

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: collaborator

Island Health, Victoria, BC

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Halton Healthcare

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nauzer Forbes, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Peter Lougheed Center

Locations

Peter Lougheed Center

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39495582 (View on PubMed)

Other Identifiers

REB 23-0438

Identifier Type: -

Identifier Source: org_study_id