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Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis
Sponsor: Westmead Hospital
Summary
Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure. This multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.
Official title: Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1300
Start Date
2026-06-01
Completion Date
2029-06-01
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Short-Stay Aggressive Hydration
Lactated Ringer's bolus 20 mL/kg over \~1 hour then 3 mL/kg/hour x 3 hours (cap 1000 mL post-procedure); rate capped at BMI 40 if BMI \> 40.
Standard Peri-procedural Hydration
Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.
Rectal Indomethacin
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
Locations (1)
Westmead Hospital
Westmead, New South Wales, Australia