Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestmead Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Short-Stay Aggressive Hydration
Other interventionLactated 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 interventionLow-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.
Rectal Indomethacin
DrugIndomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
Treatment groups
1,300 Participants
are divided into 2 treatment groupsGroup A: Aggressive HydrationExperimental treatment 2 interventions
Group B: Standard CareActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of post-ERCP pancreatitis (PEP)
PEP defined by consensus (Cotton) criteria, requiring ALL of: new or worsened upper abdominal pain; serum amylase or lipase at least 3x the upper limit of normal; pain and enzyme elevation persisting for at least 24 hours; and hospitalisation (or prolongation) of at least 2 days attributable to pancreatitis.
Time frame
Within 72 hours after ERCP (onset within 24 hours)Secondary outcomes
1
PEP not fulfilling full Cotton criteria
Post-ERCP pancreatitis not meeting full Cotton criteria.
Time frame
Within 72 hours after ERCP (onset within 24 hours)2
Delayed PEP
Post-ERCP pancreatitis (by Cotton criteria) with onset more than 24 hours after ERCP, identified after initial discharge.
Time frame
24 hours to 30 days after ERCP3
Severity of PEP
Severity graded by Cotton criteria and the Revised Atlanta Classification
Time frame
Within 30 days after ERCP4
ERCP associated adverse events
ERCP-associated adverse events graded by consensus (Cotton) criteria as mild, moderate, or severe: bleeding, perforation, and infection (cholangitis).
Time frame
Within 30 days after ERCPSponsors and contacts
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Source ClinicalTrials.gov