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A 4-Hour IV drip could stop a common Post-ERCP complication

NCT ID NCT07776561

Prevention Sponsor: Westmead Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether giving a rapid, short course of IV fluids (Lactated Ringer's) along with a rectal anti-inflammatory drug (indomethacin) can prevent pancreatitis, a common and serious complication after ERCP, a procedure used to diagnose and treat bile duct issues. The study enrolls 1,300 adults undergoing ERCP, randomly assigning half to receive the aggressive short hydration and the other half to standard low-volume fluids, with everyone getting indomethacin. The goal is to see if the short hydration reduces the rate of post-ERCP pancreatitis while allowing patients to be discharged the same day.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Short-stay aggressive hydration with Lactated Ringer's solution plus rectal indomethacin
What this could lead to
If effective, this short hydration regimen could become a standard way to prevent post-ERCP pancreatitis, allowing more patients to go home the same day.
What could go wrong
The trial is still testing the approach, and the short hydration window may not be as protective as longer regimens. Risks include fluid overload, especially in patients with heart or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute pancreatitis pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatitis Post-ercp pancreatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

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