Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

Sponsor
Westmead Hospital
Study ID
NCT07776561
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Jun 1, 2026
Status verified
Aug 2026
Primary completion
Dec 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
1,300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Aggressive Hydration
    Rectal indomethacin 100 mg plus short-stay aggressive hydration: Lactated Ringer's bolus 20 mL/kg over \~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL).
  • Active Comparator: Standard Care
    Rectal indomethacin 100 mg plus standard low-volume hydration at proceduralist/anaesthetist discretion (Lactated Ringer's up to 1.5 mL/kg/hour, max 500 mL over 3 hours).

Primary Outcome Measure

Incidence of post-ERCP pancreatitis (PEP) [ Time Frame: Within 72 hours after ERCP (onset within 24 hours) ]

Central Contacts

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