An interventional study of Short-Stay Aggressive Hydration and Standard Peri-procedural Hydration in Post-ERCP Pancreatitis and Pancreatitis, sponsored by Westmead Hospital. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Westmead Hospital · Not applicable, Interventional, and Prevention
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.
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Short-Stay Aggressive Hydration · Drug: Rectal Indomethacin
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).
Other: Standard Peri-procedural Hydration · Drug: Rectal Indomethacin
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.
Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
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)
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)
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 ERCP
Severity of PEP
Severity graded by Cotton criteria and the Revised Atlanta Classification
Time frame: Within 30 days after ERCP
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 ERCP
Signs of fluid overload
Pulmonary oedema, peripheral (pitting) oedema, or exacerbation of congestive cardiac failure.
Time frame: Peri-procedural to 24 hours after ERCP
Hospitalization for any reason within 30 days
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.
Time frame: Within 30 days after ERCP
Cost effectiveness
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.
Time frame: Within 30 days after ERCP
Hospitalization Length of Stay
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.
Time frame: Within 30 days of ERCP
Hospitalization for PEP Length of Stay
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.
Time frame: Within 30 days of ERCP
Plan to share: No
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