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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatitis; ERCP Surgery
• Intervention / Treatment: Procedure: Cold water; Procedure: Warm water

Detailed Description

Study design:

This is an investigator-initiated, single-center, triple-blind, parallel-group, randomized controlled superiority trial. Participants will be randomized 1:1 to receive either (1) rectal indomethacin plus cold water irrigation or (2) rectal indomethacin plus room-temperature water irrigation. The study is designed to evaluate whether cold water irrigation provides additive benefit in reducing the incidence of post-ERCP pancreatitis (PEP) compared with standard therapy.

Eligible patients (≥20 years, native papilla) undergoing ERCP at University of Kansas Medical Center (KUMC) will be identified during pre-procedure evaluation. Written informed consent will be obtained prior to the procedure.

Baseline Data Collection: Demographic data, relevant medical history, ERCP indication, and risk factors for PEP will be recorded before the procedure.

All patients receive a 100 mg rectal indomethacin suppository at the completion of ERCP.

Participants are randomized to receive either 250 mL of cold water (experimental arm) or room-temperature water (control arm) directed toward the papilla in five 50 mL aliquots, with aspiration between each injection.

Monitoring During ERCP: Continuous monitoring of heart rate, non-invasive blood pressure, oxygen saturation, and sedation status will be performed throughout the procedure per standard of care.

Post-Procedure Monitoring: Patients will be monitored in the recovery unit and inpatient setting as clinically indicated. Laboratory tests (amylase, lipase, Complete Blood Count (CBC), metabolic panel) will be obtained if patients develop post-procedure abdominal pain or clinical suspicion of pancreatitis.

Risk Minimization, Drugs/Devices, and Source Records :

• Risk Minimization: All patients receive guideline-recommended NSAID prophylaxis (indomethacin).Cold water irrigation volume and temperature are standardized to avoid mucosal injury or systemic effects. Experienced endoscopists will perform all procedures. Patients will be closely monitored during and after ERCP for early recognition of adverse events.

• Drugs/Devices: Rectal indomethacin (100 mg suppository) - FDA-approved NSAID, used off-label for PEP prevention.

Sterile water for irrigation (cold or room temperature) - procedural adjunct, not investigational.

• Source Records: Electronic medical record (Epic) for demographics, labs, and hospital course. Procedure reports and nursing documentation. Case report forms (CRFs) and study data collection sheets maintained in a secure REDCap database.

• Study Type: Interventional
• Enrollment (Estimated): 950
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reza Hejazi; Phone Number: 913-588-6019; Email: rhejazi@kumc.edu
• Study Contact Backup: Name: Roham Salman Roghani; Phone Number: Salman Roghani; Email: rsalmanroghani@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Cancer Center
      • Contact: Reza Hejazi; Phone Number: 913-588-6019; Email: rhejazi@kumc.edu
      • Contact: Roham Salman Roghani; Phone Number: 913-588-6019; Email: rsalmanroghani@kumc.edu
      • Principal Investigator: Reza Hejazi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Cold water; Rectal indomethacin plus cold water irrigation
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.	Procedure: Warm water; Rectal indomethacin plus room-temperature water irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups	The incidence of post-ERCP pancreatitis (PEP) is defined according to established consensus criteria as new or worsened abdominal pain persisting for at least 24 hours after ERCP, accompanied by serum amylase or lipase levels ≥3 times the upper limit of normal at approximately 24 hours post-procedure, and necessitating hospital admission or prolongation of planned observation.	approximately 24-36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of post-ERCP pancreatitis	Severity of post-ERCP pancreatitis will be classified per the Revised Atlanta Classification (mild, moderate, or severe), based on organ failure, its duration, and local or systemic complications, with follow-up through 7 days post-ERCP	Up to 7 days post-ERCP

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay Following ERCP	Total number of days hospitalized from the day of ERCP through Day 7 post-ERCP.	Up to 7 days post-ERCP
Requirement for Additional Interventions Related to Post-ERCP Pancreatitis	Proportion of participants requiring additional interventions related to post-ERCP pancreatitis, including intensive care unit (ICU) admission or surgical or radiologic intervention.	Up to 7 days post-ERCP
Incidence of Other ERCP-Related Adverse Events	Proportion of participants experiencing ERCP-related adverse events other than post-ERCP pancreatitis, including bleeding, perforation, cholangitis, or cardiopulmonary complications.	Up to 7 days post-ERCP

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Reza Hejazi, University of Kansas

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prevention; ERCP; Pancreatitis; Cold Water
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: KU-IIS-RH-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All personnel involved in this project are the University of Kansas (KU)-affiliated physicians/researchers; therefore, there are no anticipated issues regarding the sharing of individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No