Short-stay aggressive hydration to prevent post-ERCP pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, randomized trial, adults having ERCP are assigned to either aggressive peri-procedural hydration with Lactated Ringer's solution plus rectal indomethacin or standard low-volume hydration with rectal indomethacin. The primary goal is to see if the aggressive hydration approach reduces the incidence of post-ERCP pancreatitis, defined by standard criteria. The study uses intention-to-treat analysis and follows both short-term (pre-discharge and 24-hour) and medium-term (30-day) outcomes. Pancreatic duct stenting is allowed per guidelines, and hydration is stopped if fluid overload occurs.

Why it matters

Who can join: the full rules

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

Where it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Nicholas Burgess — Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia
• Study coordinator: Nicholas Burgess
• Email: nicholas.burgess@health.nsw.gov.au
• Phone: +61288905555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.