Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis (NCT06260878) | Clinical Trial Compass
RecruitingPhase 4
Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
Canada505 participantsStarted 2024-11-22
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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