Cold Water Irrigation for Pancreatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Reza Hejazi
Principal Investigator
University of Kansas
Are You a Good Fit for This Trial?
This trial is for individuals who have undergone an ERCP procedure, which is a type of endoscopic surgery used to examine the pancreatic and bile ducts. Participants should not currently be experiencing pancreatitis or pancreatic insufficiency.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ERCP with either cold water or room-temperature water irrigation after receiving rectal indomethacin
Post-Procedure Monitoring
Participants are monitored in the recovery unit and inpatient setting for signs of pancreatitis and other adverse events
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up for severity of post-ERCP pancreatitis
What Are the Treatments Tested in This Trial?
Interventions
- Cold Water Irrigation Therapy
Trial Overview
The study investigates if rinsing the papilla with cold water after an ERCP can reduce the risk of developing post-ERCP pancreatitis compared to using warm water, alongside standard medication like Indomethacin.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
• 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.
• Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Kansas Medical Center
Lead Sponsor
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