RECRUITING Not applicable ClinicalTrials.gov

Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

Sponsor: Westmead Hospital • ClinicalTrials.gov ID: NCT07776561

Registry updated: 2026-08-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Short-Stay Aggressive Hydration (Other)
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 (Other)
Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.
Rectal Indomethacin (Drug)
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.

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

Conditions

Post-ERCP Pancreatitis Pancreatitis

Locations

Westmead Hospital — Westmead, New South Wales, Australia

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment