RecruitingPhase 4NCT06260878

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

Sponsor

University of Calgary

Enrollment

505 participants

Start Date

Nov 22, 2024

Study Type

INTERVENTIONAL

Conditions

Post-ERCP Acute Pancreatitis

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria12

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