Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis

Recruiting now · Phase 4

Conditions studied: Post-ERCP Acute Pancreatitis

In brief

This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.

Key facts

Study ID

NCT06260878

Run by

University of Calgary

People needed

505

Starts

2024-11-22

Expected to finish

2028-12-31

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age)
• ability to give informed consent
• native major papillary anatomy
• ability and willingness to obtain bloodwork the day after ERCP

You may not qualify if…

• prior ERCP with sphincterotomy and/or sphincteroplasty
• confirmed or suspected cholangitis or sepsis
• confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
• NYHA Class II or greater heart failure
• active pulmonary edema
• myocardial infarction or ischemia within the preceding 3 months
• renal insufficiency with CrCl < 40 mL/minute
• CPT Class B or C cirrhosis and/or end-stage liver disease
• room air oxygen saturation <90% or requirement of home O2
• hypernatremia with Na+ ≥ 150 mEq/L or Na+ <130 mEq/L
• uncontrolled hypertension or hypotension
• pregnant status

Where it is running

• Peter Lougheed Centre — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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