Recruiting

Cold Water Rinse

Sponsor:

University of Kansas Medical Center

Code:

NCT07330284

Conditions

Pancreatitis

ERCP Surgery

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Cold water

Warm water

Study Details

Brief 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.

Conditions

Pancreatitis

ERCP Surgery

Study ID

NCT07330284

Start date

Dec 5, 2025

Status verified date

May, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

950 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Cold water

Rectal indomethacin plus cold water irrigation

Warm water

Rectal indomethacin plus room-temperature water irrigation

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Reza Hejazi

913-588-6019rhejazi@kumc.edu

Roham Salman Roghani

Salman Roghanirsalmanroghani@kumc.edu

Locations

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Reza Hejazi

913-588-6019rhejazi@kumc.edu

Roham Salman Roghani

913-588-6019rsalmanroghani@kumc.edu

Principal Investigator:

Reza Hejazi

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Keywords

  • Cold Water
  • Prevention
  • ERCP
  • Pancreatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-07.