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Cold Water Irrigation for Post-ERCP Pancreatitis Prevention

This study is looking at whether adding cold water rinsing to a standard treatment can help prevent pancreatitis (inflammation of the pancreas) after an ERCP procedure. An ERCP is a procedure that uses a scope and X-rays to diagnose and treat problems in the bile and pancreatic ducts. All participants will receive rectal indomethacin, a medicine given to reduce inflammation. Some will also receive cold water rinsing, while others will receive room-temperature water rinsing. The study aims to see if cold water helps lower the chance of developing pancreatitis after ERCP. You may be able to join if you are at least 20 years old, have a native papilla (the opening where bile and pancreatic ducts join), and are having an ERCP. The study plans to enroll 950 people and is currently unclear on its recruitment status.

Study design
This is a randomized controlled study where participants are randomly assigned to one of two groups. It is a triple-blind study, meaning you, your doctor, and the researchers won't know which treatment you are receiving.
What's involved
You will have an ERCP procedure and receive a rectal indomethacin suppository. During the ERCP, you will receive either cold water or room-temperature water rinsing.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study, the incidence of pancreatitis, will be measured at approximately 24-36 months after the procedure.

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NCT07330284

Cold Water Irrigation Therapy as an Adjunct to Indomethacin for Post-Endoscopic Retrograde Cholangiopancreatography(ERCP) Pancreatitis

Recruiting
NAAges 20+InterventionalPrevention
University of Kansas Medical Center
~950 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Cold waterWarm water

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups
Measured over approximately 24-36 months.

Conditions

Pancreatitis
ERCP Surgery

Explore related trials

Pancreatitis

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Reza Hejazi · PRINCIPAL_INVESTIGATOR · University of Kansas

Who to contact

Reza Hejazi
[email protected]
913-588-6019
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Native papilla present.
Undergoing ERCP for diagnostic or therapeutic indications.
Able to provide informed consent.

Exclusion

Post-operative reconstructed intestinal tract other than Billroth I reconstruction.
Acute pancreatitis at the time of ERCP.
Chronic pancreatitis.
Pancreatic head cancer with occlusion of the main pancreatic duct.
Existing pancreatic duct stent or need for prophylactic pancreatic duct stenting during the index ERCP.
Known contraindications or allergy to indomethacin or other NSAIDs.
Significant renal impairment (eGFR \< 30 mL/min/1.73m²).
Active peptic ulcer disease or history of NSAID-induced gastrointestinal bleeding.

What this trial measures

  • Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groupsapproximately 24-36 months.

    The incidence of post-ERCP pancreatitis (PEP) is defined according to established consensus criteria as new or worsened abdominal pain persisting for at least 24 hours after ERCP, accompanied by serum amylase or lipase levels ≥3 times the upper limit of normal at approximately 24 hours post-procedure, and necessitating hospital admission or prolongation of planned observation.