Cold water rinse plus rectal indomethacin to prevent pancreatitis after ERCP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, triple-blind, single-center trial at the University of Kansas Medical Center randomizes adults with a native papilla 1:1 to receive either 250 mL cold water (in five 50 mL aliquots) or room-temperature water directed at the papilla in addition to a 100 mg rectal indomethacin suppository given at ERCP completion. Baseline demographics, ERCP indication, and PEP risk factors are recorded before the procedure, with continuous intra-procedure monitoring and standard post-procedure observation. The primary outcome is the incidence of post-ERCP pancreatitis comparing the cold-water arm versus the room-temperature control. Key exclusions include chronic pancreatitis, existing pancreatic duct stents or need for prophylactic stenting, NSAID contraindications, significant renal impairment, and certain post-operative reconstructions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where it's running

• University of Kansas Cancer Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: Reza Hejazi — University of Kansas
• Study coordinator: Reza Hejazi
• Email: rhejazi@kumc.edu
• Phone: 913-588-6019

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.