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

NCT07330284 | Not Yet Recruiting DMC

• 1 other identifier: KU-IIS-RH-2025-01
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 1

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

Keywords

Cold Water; Prevention; ERCP; Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Severity of post-ERCP pancreatitis

  Up to 7 days post-ERCP

Other Outcomes (3)

• Length of Hospital Stay Following ERCP

  Up to 7 days post-ERCP

• Requirement for Additional Interventions Related to Post-ERCP Pancreatitis

  Up to 7 days post-ERCP

• Incidence of Other ERCP-Related Adverse Events

  Up to 7 days post-ERCP

Study Arms (2)

Cold Water

EXPERIMENTAL

• 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

Warm water

PLACEBO COMPARATOR

• Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery.

Procedure: Warm water

Interventions

Warm water PROCEDURE

Rectal indomethacin plus room-temperature water irrigation

Warm water

Cold water PROCEDURE

Rectal indomethacin plus cold water irrigation

Cold Water

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Reza Hejazi

  University of Kansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Hejazi

CONTACT

913-588-6019; rhejazi@kumc.edu

Roham Salman Roghani

CONTACT

Salman Roghani; rsalmanroghani@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: January 9, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)