Cold water rinse plus rectal indomethacin to prevent pancreatitis after ERCP
Adjunctive Cold Water Irrigation Added to Rectal Indomethacin for Prevention of Post- Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
This will test whether rinsing the papilla with cold water plus a rectal indomethacin dose lowers the chance of pancreatitis for adults undergoing ERCP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 950 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07330284 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, single-center trial at the University of Kansas Medical Center randomizes adults with a native papilla 1:1 to receive either 250 mL cold water (in five 50 mL aliquots) or room-temperature water directed at the papilla in addition to a 100 mg rectal indomethacin suppository given at ERCP completion. Baseline demographics, ERCP indication, and PEP risk factors are recorded before the procedure, with continuous intra-procedure monitoring and standard post-procedure observation. The primary outcome is the incidence of post-ERCP pancreatitis comparing the cold-water arm versus the room-temperature control. Key exclusions include chronic pancreatitis, existing pancreatic duct stents or need for prophylactic stenting, NSAID contraindications, significant renal impairment, and certain post-operative reconstructions.
Who should consider this trial
Good fit: Adults (≥20 years) with a native papilla undergoing ERCP at KUMC who can provide informed consent and meet eligibility criteria are ideal candidates.
Not a fit: Patients with chronic pancreatitis, active acute pancreatitis, existing pancreatic duct stents or need for stenting, NSAID contraindications, significant renal impairment, or certain surgical reconstructions are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could reduce rates of post-ERCP pancreatitis and related hospital stays and complications.
How similar studies have performed: Rinsing the papilla with cold water is a novel adjunctive approach with limited prior clinical data, so large-scale success has not yet been demonstrated.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Reza Hejazi — University of Kansas
- Study coordinator: Reza Hejazi
- Email: rhejazi@kumc.edu
- Phone: 913-588-6019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.