Hereditary Pancreatitis Clinical Trials

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Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age over 18 years

• Undergoing ERCP

• Able to provide informed consent

Locations
Other Locations
Australia
Westmead Hospital
RECRUITING
Westmead
Contact Information
Primary
Nicholas Burgess
nicholas.burgess@health.nsw.gov.au
+61288905555
Backup
Brian Lam
briannicholas.lam@mail.utoronto.ca
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 1300
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Westmead Hospital

This content was sourced from clinicaltrials.gov