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Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

RecruitingNA

Sponsor: Westmead Hospital

Conditions: Post-ERCP Pancreatitis, Pancreatitis

Interventions: Short-Stay Aggressive Hydration, Standard Peri-procedural Hydration, Rectal Indomethacin

Countries: Australia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Westmead, New South Wales, Australia