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Extra fluids during ERCP may prevent pancreatitis, study finds

NCT ID NCT07417020

Prevention Sponsor: Lahore General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving more IV fluids (aggressive hydration) during an ERCP procedure can prevent pancreatitis, a common complication. 126 adults having their first ERCP were randomly assigned to receive either standard or extra fluids. The goal was to see if extra fluids reduce the risk of post-procedure pancreatitis.

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

126 people

The number who actually took part.

Started

Mar 2024

Finished

Mar 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 70 years

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: * Patients aged between 18 to 70 years. * Both males and females. * Patients undergoing their first Endoscopic Retrograde Cholangiopancreatography (ERCP) for choledocholithiasis, bile duct leak, or biliary obstruction. Exclusion Criteria: * Patients who have previously undergone an ERCP, endoscopic sphincterectomy, or endoscopic papillary balloon dilatation. * Individuals with a known history of chronic pancreatitis, ongoing acute pancreatitis, or patients with gallstone pancreatitis or active cholangitis. * Patients with coagulopathy or those on anticoagulation therapy. * Pregnant or lactating women. * Substance abuse: Individuals with a history of alcohol or other substance abuse disorders. * Patients having hypernatremia or hyponatremia (Na \<130 or Na \>150 mEq/L) or Hyperkalemia (\>5.1 mEq/dL). * Specific organ dysfunctions: * Patients with organ dysfunctions including cardiac insufficiency (New York Heart Association Class II or above), respiratory insufficiency (oxygen saturation \<90%), renal insufficiency (creatinine clearance \<40 mL/min), or liver dysfunction. * Clinical signs of fluid overload, specifically peripheral or pulmonary edema, and ongoing hypotension, including those with sepsis. * Patients undergoing sphincterotomy as it reduces the risk of pancreatitis.

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Conditions

The condition(s) this trial relates to.

bile duct disorder choledocholithiasis cholestasis pancreatitis acute pancreatitis prevention target

As listed by the trial registrant

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

Bile duct disorder Biliary obstruction Choledocholithiasis Endoscopic retrograde cholangiopancreatography (ERCP)

Contacts and locations

Locations

  • Lahore General Hospital, Lahore

    Lahore, Punjab Province, 54000, Pakistan

More trials for these conditions

Other studies related to the condition(s) this trial covers.