Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Ringer's lactate.
- Who it may be relevant to
- Registry conditions: Post-ERCP Acute Pancreatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Intravenous Ringer's lactate
Intravenous Ringer's lactate
Primary outcome measures
- Serum amylase [Time frame: 24 hours]
Secondary outcome measures (8)
- Pancreatitis [Time frame: 7 days]
- Bleeding [Time frame: 30 days]
- Cholangitis [Time frame: 14 days]
- Cardiorespiratory adverse event [Time frame: 7 days]
- Serum lipase [Time frame: 24 hours]
- Electrolytes [Time frame: 24 hours]
- Creatinine [Time frame: 24 hours]
- Brain natriuretic peptide [Time frame: 24 hours]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- Peter Lougheed Centre — Calgary
Publications
- Forbes N, Guo H, Kruk A, Ficaccio S, Cartwright S, Howarth M, Malik G, Nietert PJ, Smith ZL, Li S, Chen YI, Causada Calo N, Tse F, Telford JJ, Cook DJ, Hill MD, Elmunzer BJ. Short-term intravenous fluids for prevention of post-ERCP pancreatitis (the STRIPE study): protocol for a five-arm randomised controlled trial. BMJ Open. 2026 May 27;16(5):e119154. doi: 10.1136/bmjopen-2026-119154. PMID 42203288
Identifiers
NCT: NCT06260878 · REB23-0625