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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Intravenous Ringer's lactate

Treatment groups

505 Participants
are divided into 5 treatment groups

Sponsors and collaborators