Incidence and Predictors of Bleeding During and Following ERCP

Incidence and Predictors of Bleeding During and Following Endoscopic Retrograde Cholangiopancreatography

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.

Study Overview

• Status: Completed
• Conditions: Bleeding UGI (During or Post-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.

• Study Type: Observational
• Enrollment (Actual): 5872

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Peter Lougheed Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Radboud University Medical Center; McGill University; University of Toronto; University of Ottawa; Queen's University; Island Health, Victoria, BC; Halton Healthcare
• Investigators: Principal Investigator: Nauzer Forbes, MD MSc, Peter Lougheed Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Post-ERCP Bleeding; Intraprocedural Bleeding
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: REB 23-0438

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No