Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis (STRIPE)

University of Calgary

Status and phase: Enrolling; Phase 4

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Other: Intravenous Ringer's lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT06260878

REB23-0625

Details and patient eligibility

About

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.

Enrollment: 505 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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505 participants in 5 patient groups

Ringer's lactate 2500 cc IV

Experimental group

Treatment:

Other: Intravenous Ringer's lactate

Ringer's lactate 2000 cc IV

Experimental group

Treatment:

Other: Intravenous Ringer's lactate

Ringer's lactate 1500 cc IV

Experimental group

Treatment:

Other: Intravenous Ringer's lactate

Ringer's lactate 1000 cc IV

Experimental group

Treatment:

Other: Intravenous Ringer's lactate

Ringer's lactate 500 cc IV

Active Comparator group

Treatment:

Other: Intravenous Ringer's lactate