RecruitingNot ApplicableNCT07330284

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

Adjunctive Cold Water Irrigation Added to Rectal Indomethacin for Prevention of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis


Sponsor

University of Kansas Medical Center

Enrollment

950 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria3

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

Exclusion Criteria8

  • 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.

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Interventions

PROCEDURECold water

Rectal indomethacin plus cold water irrigation

PROCEDUREWarm water

Rectal indomethacin plus room-temperature water irrigation


Locations(1)

University of Kansas Cancer Center

Kansas City, Kansas, United States

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NCT07330284


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