About this trial
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.
Eligibility criteria
Qualifiers
Age over 18 years
Undergoing ERCP
Able to provide informed consent
Disqualifiers
Unable to give consent
Clinical signs/symptoms of congestive cardiac failure (pitting oedema, NYHA class ≥ 2, or oxygen saturation ≤ 90%)
Respiratory failure (pre-procedure SpO2 < 90% on room air, or requirement for non-invasive/mechanical ventilation)
Contraindication to rectal NSAIDs (allergy; active gastrointestinal bleeding)
Trial design
Treatments tested in this trial
- Short-Stay Aggressive Hydration
- Standard Peri-procedural Hydration
- Rectal Indomethacin