Cold Water Irrigation for Pancreatitis

RH
RS
Overseen ByRoham Salman Roghani
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center

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?

RH

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

Able to provide informed consent
My natural body duct opening is intact.
I am scheduled for an ERCP procedure.

Exclusion Criteria

I am currently experiencing acute pancreatitis.
I have chronic pancreatitis.
I have an active stomach ulcer or a history of bleeding caused by pain relievers.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ERCP with either cold water or room-temperature water irrigation after receiving rectal indomethacin

1 day
1 visit (in-person)

Post-Procedure Monitoring

Participants are monitored in the recovery unit and inpatient setting for signs of pancreatitis and other adverse events

Up to 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up for severity of post-ERCP pancreatitis

Up to 7 days

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

Group I: Cold WaterExperimental Treatment1 Intervention
Group II: Warm waterPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials
527
Recruited
181,000+