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Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

NCT07776561 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Short-Stay Aggressive Hydration

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.

OTHER

Standard Peri-procedural Hydration

Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.

DRUG

Rectal Indomethacin

Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.

Sponsors & Collaborators

  • Westmead Hospital

    lead OTHER

Principal Investigators

  • Nicholas Burgess · Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-12-01
Completion
2029-06-01

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07776561 on ClinicalTrials.gov