IV Fluids and Post-ERCP Pancreatitis

NCT05211206 | Recruiting

• 1 other identifier: REB21-1885
• Study Type: observational
• Target: 13,000
• Locations: 1 country
• Sites: 1

Brief Summary

Aggressive intravenous hydration has been shown in randomized trials to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), though studied regimens are often impractical. To date, no studies have prospectively assessed short-term (60-90 minute) aggressive hydration regimens that are feasible for outpatients undergoing ERCP and subsequent discharge. Furthermore, little is known with regard to fluid type, volume, and timing with respect to ERCP. In this study, we will aim to assess whether the amount of peri-procedural intravenous fluid administered around the time of ERCP is associated with the risk of PEP (the primary outcome).

Conditions

ERCP

Outcome Measures

Primary Outcomes (1)

• post-ERCP pancreatitis

  Number of participants with any 2 of: (1) epigastric abdominal pain, (2) serum amylase/lipase \>3x the upper limit of normal, (3) imaging findings consistent with acute pancreatitis

  30 days

Study Arms (2)

Aggressive hydration

Patients with greater than or equal to 2 L of intravenous crystalloid fluids administered within the immediate pre-, peri- and post-procedural period

Other: IV fluids

Conservative hydration

Patients with less than 1 L of intravenous crystalloid fluids administered within the immediate pre-, peri- and post-procedural period

Other: IV fluids

Interventions

IV fluids OTHER

Amount of intravenous fluids delivered

Aggressive hydration; Conservative hydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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
• Halton Health (Oakville): collaborator
• Island Health, Victoria, BC: collaborator

Study Sites (1)

Peter Lougheed Hospital

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Nauzer Forbes, MD MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nauzer Forbes, MD MSc

CONTACT

403-592-5089; nauzer.forbes@ucalgary.ca

Study Design

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

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 10, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CA (1)