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

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT07330284
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cold water — PROCEDURE
    Rectal indomethacin plus cold water irrigation
  • Warm water — PROCEDURE
    Rectal indomethacin plus room-temperature water irrigation

Study Details

This study is designed to learn whether rinsing the papilla with cold water at the end of an ERCP procedure, in addition to standard medicine, can help lower the chance of developing pancreatitis, which is the most common major complication after ERCP.

Key Dates

Start date
Dec 5, 2025
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
950 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cold Water
    • Cold Water Irrigation of the Papilla: Participants randomized to the experimental arm will receive 250 mL of refrigerated water (target temperature 4-8 °C) in five 50 mL aliquots directed toward the papilla, with duodenal aspiration after each aliquot.
  • Placebo Comparator: Warm water
    • Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery.

Primary Outcome Measure

Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups [ Time Frame: approximately 24-36 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160
Reza Hejazi
[email protected]
913-588-6019
Roham Salman Roghani
[email protected]
913-588-6019
Reza Hejazi (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Cancer Center· Kansas City, KS

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