PancreatitisNCT07330284
Cold Water Irrigation Therapy as an Adjunct to Indomethacin for Post-Endoscopic Retrograde Cholangiopancreatography(ERCP) Pancreatitis
A study testing Cold water and Warm water in people with Pancreatitis and ERCP Surgery, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatitis, ERCP Surgery
- What is being tested?
- Cold water and Warm water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 950 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Native papilla present.
- Undergoing ERCP for diagnostic or therapeutic indications.
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Reza Hejazi, 913-588-6019, rhejazi@kumc.edu
Roham Salman Roghani, 913-588-6019, rsalmanroghani@kumc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatitis, ERCP Surgery
- Being tested
- Cold water, Warm water
- Keywords
- Cold Water, Prevention, ERCP, Pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold waterProcedure or surgery
Rectal indomethacin plus cold water irrigation
Warm waterProcedure or surgery
Rectal indomethacin plus room-temperature water irrigation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Warm water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 24-36 months.
Secondary outcomes (1)
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
Measured: Up to 7 days post-ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start5 Dec 2025
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Hejazi, University of Kansas Medical Center
- Investigators
- Reza Hejazi, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330284
- Sponsor's protocol ID
- KU-IIS-RH-2025-01
- Status last verified
- May 2026
- First submitted
- 6 Nov 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Cold Water Irrigation Added to Rectal Indomethacin for Prevention of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
- ClinicalTrials.gov ID
- NCT07330284
- Acronym / sponsor ID
- KU-IIS-RH-2025-01
- Conditions
- Pancreatitis, ERCP Surgery
- Keywords
- Cold Water, Prevention, ERCP, Pancreatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold Water | Experimental | Procedure: 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. |
| Warm water | Placebo comparator | Procedure: Warm water• Control Intervention: Participants randomized to the control group will receive 250 mL of room-temperature water in identical increments and delivery. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Native papilla present.
- Undergoing ERCP for diagnostic or therapeutic indications.
- Able to provide informed consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold waterRectal indomethacin plus cold water irrigation | Procedure or surgery | Cold Water |
| Warm waterRectal indomethacin plus room-temperature water irrigation | Procedure or surgery | Warm water |
Primary outcome
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups
Time frame: approximately 24-36 months.
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.
1 secondary outcome
Severity of post-ERCP pancreatitis
Time frame: Up to 7 days post-ERCP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reza Hejazi principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water and Warm water in people with Pancreatitis and ERCP Surgery, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reza Hejazi (913-588-6019, rhejazi@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-ERCP Pancreatitis (PEP) between the cold water and control groups (time frame: approximately 24-36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.