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Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

RecruitingNAAges 18 Years - anyAllWestmead Hospital
NCT07776561 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 def

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age over 18 years * Undergoing ERCP * Able to provide informed consent Exclusion Criteria: * 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) * Estimated GFR (MDRD) ≤ 30 mL/min * Altered biliary or duodenal anatomy (e.g. prior biliary/pancreatic surgery, Roux-en-Y reconstruction) * Known hypo- or hypernatraemia (serum sodium \< 130 or \> 150 mmol/L) * Pregnancy * Severe liver disease (cirrhosis with ascites) * Previous sphincterotomy (unless undergoing pancreatic duct intervention) * Acute pancreatitis * Chronic pancreatitis (unless undergoing a pancreatic duct intervention) * Sphincter of Oddi dysfunction * Pancreatic mass causing biliary obstruction
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What it tests

  • Short-Stay Aggressive Hydration
  • Standard Peri-procedural Hydration
  • Rectal Indomethacin
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Where

1 site
Westmead Hospital
Westmead, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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