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NCT Number: NCT07776561

Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis

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.

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Key information

Conditions

Post-ERCP Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location status: Recruiting

Location contact

Brian Lam

CONTACT

[email protected]

Nicholas Burgess

CONTACT

[email protected]

+61288905555

Nicholas Burgess

PRINCIPAL_INVESTIGATOR

About this study

Design: multicentre, parallel-group, superiority RCT with 1:1 allocation, conducted in high-volume tertiary academic endoscopy units.

Interventions: All participants receive 100 mg indomethacin per rectum within 30 minutes before or after ERCP. Participants randomised to aggressive hydration receive a peri-procedural bolus of Lactated Ringer's 20 mL/kg over ~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL). Participants randomised to standard care receive low-volume Lactated Ringer's at the discretion of the endoscopist/anaesthetist (up to 1.5 mL/kg/hour, max 500 mL over 3 hours). For BMI > 40 kg/m2, infusion rates are capped assuming a BMI of 40. Pancreatic duct stenting is permitted in both arms at the proceduralist's discretion per guidelines. Aggressive hydration is discontinued if signs of fluid overload develop.

Follow-up: pre-discharge assessment (fluid-overload exam, pain), a 24-hour telephone follow-up (bloods if symptomatic), and a 30-day telephone follow-up for delayed events and hospitalisation.

Analysis: primary analysis by intention-to-treat; per-protocol analysis also performed. Statistical analysis is conducted blinded to allocation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of post-ERCP pancreatitis (PEP)

    Time frame: Within 72 hours after ERCP (onset within 24 hours)

    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.

Secondary outcomes

  1. PEP not fulfilling full Cotton criteria

    Time frame: Within 72 hours after ERCP (onset within 24 hours)

    Post-ERCP pancreatitis not meeting full Cotton criteria.

  2. Delayed PEP

    Time frame: 24 hours to 30 days after ERCP

    Post-ERCP pancreatitis (by Cotton criteria) with onset more than 24 hours after ERCP, identified after initial discharge.

  3. Severity of PEP

    Time frame: Within 30 days after ERCP

    Severity graded by Cotton criteria and the Revised Atlanta Classification

  4. ERCP associated adverse events

    Time frame: Within 30 days after ERCP

    ERCP-associated adverse events graded by consensus (Cotton) criteria as mild, moderate, or severe: bleeding, perforation, and infection (cholangitis).

  5. Signs of fluid overload

    Time frame: Peri-procedural to 24 hours after ERCP

    Pulmonary oedema, peripheral (pitting) oedema, or exacerbation of congestive cardiac failure.

  6. Hospitalization for any reason within 30 days

    Time frame: Within 30 days after ERCP

    Proportion of participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP. Ascertained from medical records and the 30-day follow-up call.

  7. Cost effectiveness

    Time frame: Within 30 days after ERCP

    Cost-effectiveness of short-stay aggressive hydration versus standard care, comparing total cost of healthcare resource use (intravenous fluids and consumables, procedure/recovery time, length of stay, and PEP-related admissions or readmissions) in relation to PEP cases avoided. Reported as incremental cost effectiveness ratio (ICER) for post-ERCP pancreatitis cases avoided.

  8. Hospitalization Length of Stay

    Time frame: Within 30 days of ERCP

    In participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP, the length of hospital stay measured in days. Ascertained from medical records and the 30-day follow-up call.

  9. Hospitalization for PEP Length of Stay

    Time frame: Within 30 days of ERCP

    In participants hospitalised (including unplanned admission or readmission) for PEP within 30 days of ERCP, the length of hospital stay measured in days. Ascertained from medical records and the 30-day follow-up call.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Lam

CONTACT

[email protected]

Nicholas Burgess

CONTACT

[email protected]

+61288905555

Sponsors and collaborators

Lead sponsor

Westmead Hospital

Other

Registry information

Official study title

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

Acronym: PuSH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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